Pharmaceutical Methods最新文献

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Spectrophotometric and High Performance Liquid Chromatographic Determination of Amlodipine Besylate and Nebivolol Hydrochloride in Tablets Dosage Form 分光光度-高效液相色谱法测定苯磺酸氨氯地平和盐酸奈比洛尔片剂的含量
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.1
M. Hinge, J. Patel, Rajvi J. Mahida
{"title":"Spectrophotometric and High Performance Liquid Chromatographic Determination of Amlodipine Besylate and Nebivolol Hydrochloride in Tablets Dosage Form","authors":"M. Hinge, J. Patel, Rajvi J. Mahida","doi":"10.5530/PHM.2016.7.1","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.1","url":null,"abstract":"Introduction: Absorbance ratio spectrophotometric method and high performance liquid chromatographic method were developed for the determination of the Amlodipine Besylate and Nebivolol Hydrochloride in tablet dosage form. Methods: Absorbance ratio spectrophotometric method and high performance liquid chromatographic method were developed for the determination of the Amlodipine Besylate and Nebivolol Hydrochloride in tablet dosage form. A simple liquid chromatographic assay has been developed for the determination of Amlodipine Besylate and Nebivolol Hydrochloride. A C 18 (250×4.6 mm, 5 μ) column was used with a mobile phase consisting of Water: Acetonitrile ( pH adjusted to 3.5 with ortho phosphoric acid) at a flow rate of 1.0 ml min -1 . Quantitation was achieved with UV detection at 268 nm based on the peak height ratios. Results: Calibration curves were linear in the range of 10–30 μg/ml for Amlodipine Besylate and 10-30 μg/ml for Nebivolol Hydrochloride in absorbance ratio method. Correlation coefficient found to be close to 0.9995 for both the drugs. Accuracy for both the drugs was in the range of 99-101%. Beer’s law was obeyed in a concentration range of 10-30 mg ml -1 for Amlodipine Besylate and 10-30 mg ml -1 for Nebivolol Hydrochloride and the regression line equation was derived with a correlation coefficient of 0.9999 and 0.9998 for Amlodipine Besylate and Nebivolol Hydrochloride respectively. Discussion: The proposed procedures were successfully applied to the determination of Amlodipine Besylate and Nebivolol Hydrochloride in bulk and tablet form, with high percentage of recovery, good accuracy and precision. Key words: Amlodipine Besylate, Nebivolol Hydrochloride, Absorbance ratio method, HPLC, Tablets.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"36 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89562027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Formulation and Evaluation of Orodispersible Tablets of Granisetron Hydrochloride Using Agar as Natural Super disintegrants 琼脂为天然超级崩解剂的盐酸格拉司琼多孔分散片的研制与评价
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.3
C. Sahoo, N. Sahoo, M. Sahu, A. K. Moharana, D. Sarangi
{"title":"Formulation and Evaluation of Orodispersible Tablets of Granisetron Hydrochloride Using Agar as Natural Super disintegrants","authors":"C. Sahoo, N. Sahoo, M. Sahu, A. K. Moharana, D. Sarangi","doi":"10.5530/PHM.2016.7.3","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.3","url":null,"abstract":"The main aim of the study was to develop orodispersible tablets of Granisetron hydrochloride a selective 5-HT3 receptor antagonist (an antivomiting agent) for improving patient compliance, especially those of paediatric and geriatric categories with difficulties in swallowing. In the wet granulation method orodispersible (ORD) tablets were prepared using natural super disintegrants Agar agar. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, in vitro dispersion time, drug content and in vitro dissolution studies. The tablet formulation batch F4 was considered as the overall best formulation (with an in vitro drug release study of 99.09%). Short term stability studies (at 40 ± 2oC/75 ± 5% RH) on the best formulation indicated that there no significant changes in drug content. From the FTIR study indicated that there are no drug excipient interactions. Key words : Granisetron hydrochloride, Orodispersible tablets, FTIR spectroscopy, Wetting time, In vitro drug release study, Stability studies.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"54 1 1","pages":"17-22"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77216046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 8
Hydrolytic Degradation Kinetic Study of Balofloxacin by Stability Indicating Reversed Phase High Performance Liquid Chromatography Method 稳定性指示反相高效液相色谱法研究巴洛沙星水解降解动力学
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.7
Bhavin P. Marolia, P. Prajapati, K. Bodiwala, M. P. Vaghela, Shailesh A Shah, B. Suhagia
{"title":"Hydrolytic Degradation Kinetic Study of Balofloxacin by Stability Indicating Reversed Phase High Performance Liquid Chromatography Method","authors":"Bhavin P. Marolia, P. Prajapati, K. Bodiwala, M. P. Vaghela, Shailesh A Shah, B. Suhagia","doi":"10.5530/PHM.2016.7.7","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.7","url":null,"abstract":"Background: Balofloxacin is a third generation fluoroquinolone with a broad antibacterial spectrum ranging from gram-positive bacteria to gram-negative bacteria. It is used in treatment of uncomplicated urinary tract infections. No stability indicating analytical method has been reported for BFX. Also stress degradation studies of Balofloxacin were not found in literature. Objective: To develop and validate a stability indicating RP-HPLC method for estimation of Balofloxacin in presence of its hydrolytic degra­dation products. Materials and Method: The chromatographic separation was performed using C 18 , Grace Smart column (250 x 4.6 mm), 5 μm as the stationary phase and Water: Acetonitrile: Tri ethylamine (72:28:1 v/v/v), pH adjusted to 3.0 using ortho-phosphoric acid as mobile phase with detec­tion wavelength 294 nm. The developed method was validated according to ICH Q2R1 guideline. Balofloxacin was subjected to degradation in acidic, alkaline and neutral conditions. Results and Discussion: The linearity was established over concentration range of 20-100 μg/ml with correlation coefficient r 2 = 0.9979. Recovery of drug was achieved in the range of 99.19–101.65%. Limit of Detection and Limit of Quantitation was found to be 4.13 and 12.51 μg/ml. Balofloxacin was found to be stable under alkaline and neutral conditions, while it degraded under acidic hydrolytic condition. The retention times for Balofloxacin and its acid degradation product were found to be 7.0 ± 0.1 and 5.7 ± 0.1 minutes, respectively. Application: The developed RP-HPLC method was applied for estimation of Balofloxacin in its tablet dosage forms and results were found to be in good agreement with the labeled claim. The method was also applied for degradation kinetic study of Balofloxacin in acidic medium. Conclusion: The developed RP-HPLC method was found to be accurate, precise, specific and sensitive. It can be applied for routine analysis (assay) of tablets containing Balofloxa­cin. The degradation of Balofloxacin in all conditions was found to be first order and highest degradation was found in 2.0 N HCl at 75°C. Key words: Stability indicating HPLC method, Balofloxacin (BFX), Degradation products, Degradation kinetic study, Design expert software–9.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"65 4","pages":"39-47"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72586255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Development and Validation of a Stability-Indicating Reverse Phase HPLC-PDA Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form 稳定性指示反相高效液相色谱- pda法测定加格列净原料药和制剂的含量及验证
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.9
Ishpreet Kaur, S. Wakode, H. Singh, Satish Manachanda
{"title":"Development and Validation of a Stability-Indicating Reverse Phase HPLC-PDA Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form","authors":"Ishpreet Kaur, S. Wakode, H. Singh, Satish Manachanda","doi":"10.5530/PHM.2016.7.9","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.9","url":null,"abstract":"Objective: To develop and validate simple, authentic and stability indicating high performance liquid chromatographic method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Q2 R1 Guidelines. Methods: A C 18 Column (250×4.6 mm, 5 μm particle size) with a mobile phase consisting of Acetonitrile: orthophosphoric acid in a ratio of 55:45 v/v was employed for the chromatographic study. A flow rate of 1 ml/min with an injection volume of 20 μL was selected for this study and the proposed method was validated with different parameters such as Linearity, Precision, Accuracy, Robustness, Ruggedness, Limit of Detection (LOD) and Limit of Quantification (LOQ). Results: The separation was achieved at a temperature of 30oC and the eluents were observed by photo diode array detector set at 290 nm. A linear range of 1-6 μg/ ml with a correlation coefficient of 0.998 unfolds good linear relationship between area and concentration in calibration curve. The retention time obtained was at 6.29 min. The LOD and LOQ were found to be 0.41 μg/ml and 1.24 μg/ml respectively. A recovery of Canagliflozin in tablet formulation was observed in the range of 99.6-99.8%. Percentage assay of Canagliflozin tablets (INVOKANA®) was found to be 99.92%. The stability of the method was demonstrated by forced degradation studies of drug in which it was degraded under conditions of hydrolysis (acidic and alkaline), oxidation, photolytic and thermal stress as per ICH guideline Q1A (R2). Conclusion: The proposed method is definite, meticulous and reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form. Key words: Canagliflozin, High Performance Liquid Chromatography, Method development, Stability, Validation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"42 1","pages":"54-62"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77911930","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 19
Dividing the Tablets for Children – Good or Bad? 给孩子分药片——好还是坏?
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.4
Å. Andersson, S. Lindemalm, S. Eksborg
{"title":"Dividing the Tablets for Children – Good or Bad?","authors":"Å. Andersson, S. Lindemalm, S. Eksborg","doi":"10.5530/PHM.2016.7.4","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.4","url":null,"abstract":"Introduction: To investigate the dosing accuracy using split tablets in paediatric patients. Methods: Five brands of tablets (Alvedon ® (paracetamol), Catapresan ® (clonidine), Hydrocortone ® (hydrocortisone), Prednisolon ® (prednisolon) and Tavegyl ® (clemastine) were split into halves and quarters by hand or by using a tablet splitter. The resulting halves and quarters were weighed. Results: Three out of the five tablet brands passed the test in the Ph. Eur. (European Pharmacopoeia) for subdivision of tablets when split once and when split twice to yield quarters only one of the tablets passed the test. When also applying the limit for relative standard deviation (RSD) from the US Pharmacopoeia only one of the tablet halves passed and the other two was just outside the limit. None of the tablet quarters passed the RSD limit. Conclusion : Our results indicate that tablets larger than 8 mm might be split once. Tablets should not be split more than once, due to uncertainty in dose accuracy. There is a need for more commercially available age-appropriate formulations. Extemporaneously prepared formulations should be considered as an alternative to the use of split tablets. Key words:  Dosing accuracy, Manipulation of drugs, Paediatric patients, Subdivision of tablets, Tablet splitting","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"1 1","pages":"23-27"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91385510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 16
Development and Validation of HPTLC Method for Simultaneous Estimation of Amlodipine Besylate, Hydrochlorothiazide and Telmisartan In Their Combined Tablet Dosage Form 高效液相色谱法同时测定苯磺酸氨氯地平、氢氯噻嗪和替米沙坦复方剂型的方法建立与验证
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.8
Bhavin P. Marolia, K. Bodiwala, Shailesh A Shah, P. Prajapati, Bhavik Himmatbhai Satani, S. A. Desai
{"title":"Development and Validation of HPTLC Method for Simultaneous Estimation of Amlodipine Besylate, Hydrochlorothiazide and Telmisartan In Their Combined Tablet Dosage Form","authors":"Bhavin P. Marolia, K. Bodiwala, Shailesh A Shah, P. Prajapati, Bhavik Himmatbhai Satani, S. A. Desai","doi":"10.5530/PHM.2016.7.8","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.8","url":null,"abstract":"Background: The combination of Amlodipine Besylaye, Hydrochlorthiazide and Telmisartan is prescribed for the treatment of hypertension. An Ultra Performance Liquid Chromatography (UPLC) method has been reported for simultaneous estimation of this combination. Objective: To develop and validate HPTLC Method for simultaneous estimation of Amlodipine Besylate, Hydrochlorothiazide and Telmisartan in their combined tablet dosage form. Materials and Method: The chromatographic separation was performed using aluminum plates pre-coated with silica gel 60F254 as stationary phase and chloroform: butan-1-ol: ammonia (6: 4: 0.1, v/v/v) as mobile phase. Spectro-densitometric scanning was performed at 254 nm. The developed method was validated according to ICH Q2R1 guideline. Results and Discussion: The linearity was established over a concentration range of 200-1000 ng/band, 500-2500 ng/band and 1600-8000 ng/band with correlation coefficient r 2 = 0.9952, 0.9992 and 0.9979 for Amlodipine besylate, Hydrochlorothiazide and Telmisartan, respectively. The R f values of Amlodipine besylate, Hydrochlorothiazide and Telmisartan were found to be 0.27 ± 0.02, 0.43 ± 0.02 and 0.14 ± 0.02 respectively. Recovery of drug was achieved in the range of 99.43–101.57%, 100.22–101.54% and 100.12–100.44% for Amlodipine besylate, Hydrochlorothiazide and Telmisartan, respectively by developed method. Limit of detection and limit of quantitation was found to be 8.6, 58.0 and 186.9 ng/band and 26.1, 175.8 and 566.4 ng/band for Amlodipine besylate, Hydrochlorothiazide and Telmisartan, respectively. Application: The developed HPTLC method was applied for simultaneous estimation of three drugs in their combined tablet dosage forms and results were found to be in good agreement with the labeled claim. Conclusion: The developed HPTLC method was found to be accurate, precise, specific and sensitive. It can be applied for routine analysis (assay) of tablets containing combination of Amlodipine besylate, Hydrochlorothiazide and Telmisartan. Key words: Amlodipine besylate (AML), Hydrochlorothiazide (HCTZ), Telmisartan (TLM), High Performance Thin Layer Chromatography (HPTLC), Simultaneous estimation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"6 1","pages":"48-53"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90754961","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 10
Comparison of Two Pharmacopoeia Methods for Determining Higher Molecular Weight Proteins in Insulin Glargine 两种药典方法测定甘精胰岛素中高分子量蛋白的比较
Pharmaceutical Methods Pub Date : 2016-01-01 DOI: 10.5530/PHM.2016.7.6
G. Jadaun, Vandana Saklani, Shruti Dixit, R. Rawat, Renu Jain, G. R. Soni
{"title":"Comparison of Two Pharmacopoeia Methods for Determining Higher Molecular Weight Proteins in Insulin Glargine","authors":"G. Jadaun, Vandana Saklani, Shruti Dixit, R. Rawat, Renu Jain, G. R. Soni","doi":"10.5530/PHM.2016.7.6","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.6","url":null,"abstract":"Objective: We compared two pharmacopoeia methods, European Pharmacopoeia (EP) and Indian Pharmacopoeia (IP),with respect to their key char­acteristics for determining higher molecular weight proteins (HMWP) in insulin glargine. These methods differ in the mobile phase composition, number of HPLC columns used and run time. Material and Methods: Testing was carried out exactly as described in the respective pharmaco­poeia methods. Results: Our results indicate that both methods provide insulin glargine peak with comparable symmetry factor. Results obtained with two methods are precise in terms of intra-assay variation; however, inter-assay variation was better with IP method. Also, both methods provide similar results in terms of estimation of HMWP content in insulin glargine. Conclusion: Based on the findings we propose that IP method may replace EP method for determination of HMWP content in insulin glargine which will reduce the analysis time and running cost of the test without compromising with the results. Key words: HMWP, Insulin glargine, Monomer, Pharmacopoeia, Size exclusion HPLC.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"142 1","pages":"35-38"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83782284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Formulation and Evaluation of Gastroretentive Drug delivery System of Telmisartan 替米沙坦胃保留给药系统的研制与评价
Pharmaceutical Methods Pub Date : 2015-12-21 DOI: 10.5530/PHM.2015.6.9
M. Goyal, A. Dubey, L. Yadav
{"title":"Formulation and Evaluation of Gastroretentive Drug delivery System of Telmisartan","authors":"M. Goyal, A. Dubey, L. Yadav","doi":"10.5530/PHM.2015.6.9","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.9","url":null,"abstract":"Purpose: The aim of the present study was to develop a gastro retentive system of telmisartan to prolong its gastric residence time and bioavailability. Materials and Methods: Non aqueous solvent evaporation method was used to prepare floating microspheres of telmisartan with kollidon SR. Total five formulations were made with varying concentration of kollidon SR. Prepared floating microspheres were subjected to various evaluation parameters, such as particle size determination, SEM, percent yield, entrapment efficiency, bulk and tapped density, compressibility index, angle repose, In vitro floatability, FT-IR study and In vitro drug release. Results: All the formulations displayed good flow properties. In vitro dissolution studies in HCl buffer pH 1.2 were performed to assess the release profile of prepared floating microsphere formulations. All the five formulation displayed sustained release of drug. FT-IR spectra of formulation F3 exhibited all the peaks as similar to the FT-IR spectra of pure drug, rejecting any doubts about the compatibility between drug and the excipients. Conclusion: We can conclude that kollidon SR can be successfully used to prepare floating microspheres of telmisartan to increase its gastric residence time and bioavailability. Key words: Floating microsphere, Kollidon SR, Non aqueous solvent evaporation method, PEG 4000, Solid dispersion.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"43 1","pages":"67-71"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85369477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Estimation and quantitation of β-asarone from Acorus calamus rhizome and its formulations using validated RP-HPLC method 用反相高效液相色谱法测定菖蒲根茎中β-细辛酮及其制剂的含量
Pharmaceutical Methods Pub Date : 2015-12-21 DOI: 10.5530/PHM.2015.6.13
S. Shailajan, S. Menon, Gauri Swar, Dipti Singh, Sreenath Nair
{"title":"Estimation and quantitation of β-asarone from Acorus calamus rhizome and its formulations using validated RP-HPLC method","authors":"S. Shailajan, S. Menon, Gauri Swar, Dipti Singh, Sreenath Nair","doi":"10.5530/PHM.2015.6.13","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.13","url":null,"abstract":"Introduction: Acorus calamus Linn. ( A. calamus ) has been found use in medicines to cure fevers, for asthma, bronchitis and as an all-round sedative. β-asarone is an important phytochemical compound present richly in the rhizomes of Acorus calamus that imparts several therapeutic properties to the plant by the virtue of which the plant has occupied a significant therapeutic acclaim in ancient Ayurvedic text and is employed as one of the key ingredients in several traditional and herbal formulations. Thus, the study aims to develop and validate an efficient Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for quantification of β-asarone from rhizomes of A. calamus of the wild and marketed variety and also intends to apply the validated methods for the estimation of the biomarker from different formulations containing the rhizome as one of its ingredients. Methods: Separation was carried out on Cosmosil C 18 column eluted with mobile phase of methanol: distilled water (50:50, v/v) at flow rate of 1 mL/min. Detection was carried out at 304 nm using a photodiode array detector (PDA) and the method was validated as per International Conference on Harmonization (ICH) guidelines. Rhizome was collected from Kerala and also procured from the market.  Commercial traditional and herbal formulations like Sarasvata Curna, Maanasmitra Vatakam, Khadiradi Vati, Chandra Prabha Vati, Sanjeevani Vati, Mahashankha Vati, Smritisagara Rasa, Abana, Vacadi Taila, and Ashwagandharishtha were further subjected to RP-HPLC for separation and estimation of β-asarone. Results: The limit of detection (LOD) and limit of quantitation (LOQ) levels were found to be 0.025 µg/mL and 0.1 µg/mL, respectively. The content of β-asarone was found to be maximum in the sample collected from Kerala which was 0.2946±0.0152 mg/g. Conclusion: The developed method can be recommended for marker-based standardization and quality assurance of A. calamus and its formulations. Key words: Acorus calamus , Formulations, Rhizome, RP-HPLC, Validation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"30 1","pages":"94-99"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89000467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 10
Development and Validation of RP-HPLC Method for Estimation of Quetiapine Fumarate in Pharmaceutical Formulations 反相高效液相色谱法测定复方富马酸喹硫平含量的建立与验证
Pharmaceutical Methods Pub Date : 2015-12-21 DOI: 10.5530/PHM.2015.6.15
P. Nagaraju
{"title":"Development and Validation of RP-HPLC Method for Estimation of Quetiapine Fumarate in Pharmaceutical Formulations","authors":"P. Nagaraju","doi":"10.5530/PHM.2015.6.15","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.15","url":null,"abstract":"Objective : A simple, rapid, accurate and precise RP-HPLC method was developed for the determination of Quetiapinefumarate in pure and tablet dosage forms. Materials and Methods : Separation of the drug was achieved on aisocratic Shimadzu prominence HPLC instrument on a Waters Xterra C18 column (250x4.6 mm, 5 μ). Results : The method showed a linear response for concentration in the range of 50–150 μg/mL using buffer (9.2 ± 0.05) and acetonitrile in the ratio of 51:49 v/v with detection at 254 nm with a flow rate of 1.0 mL/min and retention time was 6.588 min. Conclusion: The method was statistically validated for linearity, accuracy, precision and selectivity. Quantitative and recovery studies of the dosage form were also carried out and analyzed, the %RSD from recovery studies was found to be less than 1. Key words: Quetiapinefumarate, Isocratic, C 18 , HPLC, Tablets.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"78 1","pages":"105-108"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83738436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
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