Pharmaceutical Methods最新文献

{"title":"Development and Validation of a HPTLC Method for the Estimation of Lornoxicam in Bulk Drug and in Tablet Dosage Form","authors":"A. Sindhu, R. Deveswaran, S. Bharath, Furtado Sharon","doi":"10.5530/PHM.2015.6.16","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.16","url":null,"abstract":"Introduction : Lornoxicam is a selective cyclooxygenase-1 and 2 inhibitor that exhibit anti inflammatory, analgesic and anti pyretic activities. It is used in the management of osteoarthritis, rheumatoid arthritis, postoperative pain and primary dysmenorrhoea. Aim : The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. Methods : The chromatographic separation was carried out on precoated silica gel 60 GF254 aluminium plates using mixture of Tetrahydrofuran: Methanol:Ethyl acetate:Ammonia (2:1.5:5.5:0.6 v/v/v/v) as mobile phase and densitometric evaluation of spots was carried out at 377 nm using CAMAG TLC Scanner-3 with win CATS 1.4.1 version software. The experimental factors like band width of spot, chamber saturation time, slit width, solvent front migration etc. were critically studied and optimum conditions were developed. Results : The drug was satisfactorily resolved with Rf value 0.34 ± 0.01. The accuracy and reliability of the proposed method was determined by evaluating various validation parameters like linearity (100-1000 ng/band), precision (intra-day RSD 0.05-0.10 %, inter-day RSD 0.04-0.13%), accuracy (98.26–100.60%) and specificity according to ICH guidelines. The drug was also subjected to acid, alkali, oxidation, thermal and photochemical degradation studies and the method was found to be effective in separating the drugs from their degradation products. Conclusion : The proposed method is simple, accurate, precise and may be used as a cost-effective quality control tool for routine analysis of Lornoxicam as bulk drug and in tablet formulation. Key words : Densitometric estimation, HPTLC, Lornoxicam, Precision, Stability, Validation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"149 1","pages":"109-114"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86132039","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}

{"title":"Development and Validation of RP-HPLC Method for Determination of Eprosartan Mesylate in Rat Plasma: Application to Preclinical Pharmacokinetic Study","authors":"P. Dangre, S. Dhole","doi":"10.5530/PHM.2015.6.14","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.14","url":null,"abstract":"A selective and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of Eprosartan mesylate in rat plasma. A single step protein precipitation was carried out with acetonitrile to deproteinized plasma sample. A chromatographic separation was achieved on a Phenomenox, Gemini C18 (250x4.6 mm, 5 μm) column using acetonitrile and water (45:55) as a mobile phase with a pH adjusted to 3.4 with orthophsophoric acid (85%) at a flow rate 1 mL/min. The intensity of peak was monitored at 235 nm. The proposed chromatographic condition shows good symmetry and resolution of peaks. The retention time of Eprosartan mesylate and Olemesartan medoxamil (Internal standard) were appropriately 2.2 ± 0.5 and 3.1 ± 0.5 min, respectively. The validation studies performed as per ICH guidelines indicated high degree of accuracy, precision, with good degree of sensitivity and robustness of the proposed method. Furthermore, no interference was observed with plasma suggesting its utility for the pharmacokinetic analysis and bioavailability study of eprosartan mesylate in rat plasma. Key words : Eprosartan mesylate, Reverse phase high performance liquid chromatography, Pharmacokinetic analysis, Protein Precipitation, Validation, ICH guidelines.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"20 1","pages":"100-104"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82263211","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}

{"title":"Quantification and Validation of Simvastatin and Ezetimibe in Bulk Drugs and Combined Dosage Form by Reverse Phase Liquid Chromatographic Method (RPLC)","authors":"N. Sahoo, M. Sahu, V. Alagarsamy, Bollu Vijaya Lalitha, A. K. Moharana, C. Sahoo","doi":"10.5530/PHM.2015.6.17","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.17","url":null,"abstract":"A simple, time saving, precise and cost effective reverse phase high performance liquid chromatographic (RP-HPLC) method developement was achieved for the determination and estimation of simvastatin and ezetimibe in its pure form and combined formulation. Separation was achieved by using Zorbax (100 × 4.6 mm, 5μ) C 18 column with mobile phase consisted of acetonitrile and methanol in a ratio of 60:40 (v/v). The separation was observed at 232 nm with flow rate adjusted to 1 ml/min. Simvastatin and ezetimibe were retained at 9.603 and 3.861 minutes successively. Validation was done for the developed method based upon different parameters like linearity, accuracy, precision, limit of detection and limit of quantitation. Simvastatin and ezetimibe obey Beer-Lambert’s law in the range of 20.0-160µg/ml and 5-40µg/ml respectively. The % recoveries of simvastatin and ezetimibe were found to be 101.25% and 102.03% respectively from the tablet formulation. The limit of detection of simvastatin and ezetimibe were found to be 1.34µg/ml and 0.253µg/ml successively. The limit of quantitation of simvastatin and ezetimibe were found to be 4.489µg/ml and 0.846µg/ml successively. The established method is suitable for simultaneous estimation of simvastatin and ezetimibe in their pure forms and combined formulation. Key words : Simvastatin, Ezetimibe, RP-HPLC, Simultaneous estimation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"44 1","pages":"115-119"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85782350","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}

{"title":"Spectrophotometric and High Performance Liquid Chromatographic Determination (HPLC) of Triprolidine and Pseudoephedrine Hydrochloride in Tablet Dosage Form","authors":"M. Hinge, K. R. Patel, Rajvi J. Mahida","doi":"10.5530/PHM.2015.6.12","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.12","url":null,"abstract":"First order derivative spectrophotometric method and high performance liquid chromatographic method were developed for the determination of Triprolidine and Pseudoephedrine Hydrochloride in tablet dosage form. In UV-Spectrophotometric method, estimation of Triprolidine and Pseudoephedrine Hydrochloride was carried out at the wavelength selected 246.20 nm and 263.50 nm for First order Derivative method. Calibration curves were linear in the range of 2-10 μg ml -1 for Triprolidine and 48-240 μg ml -1 for Pseudoephedrine Hydrochloride in derivative method. Correlation coefficient found to be close to 0.9950 for both the drugs. Accuracy for both the drugs was in the range of 99-101.5%. A simple liquid chromatographic assay has been developed for the determination of Triprolidine and Pseudoephedrine Hydrochloride. A C 18 ( 250×4.6mm, 5 μm) column was used with a mobile phase consisting of Methanol: Water (80: 20 v/v) (pH adjusted to 3.0 with ortho phosphoric acid) at a flow rate of 1.0 ml min -1 . Quantitation was achieved with UV detection at 246.20 nm based on the peak height ratios. Beer's law was obeyed in a concentration range of 5-25 mg ml -1 for Triprolidine and 120-600 mg ml -1 for Pseudoephedrine Hydrochloride and the regression line equation was derived with a correlation coefficient of 0.9999 and 0.9998 for Triprolidine and Pseudoephedrine Hydrochloride. The proposed procedures were successfully applied to the determination of Triprolidine and Pseudoephedrine Hydrochloride in bulk and tablet form, with high percentage of recovery, good accuracy and precision. Key words: Triprolidine, Pseudoephedrine Hydrochloride, Derivative method, HPLC method, Tablets.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"5 1","pages":"87-93"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81167967","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}

{"title":"Assessment of Pharmaceutical Store and Inventory Management in Rural Public Health Facilities – A study with reference to Udupi District, Karnataka","authors":"M. Kokilam, H. Joshi, V. Kamath","doi":"10.5530/PHM.2015.6.7","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.7","url":null,"abstract":"Inventory management is the core of pharmaceutical supply system. It is all about ordering, receiving, storing, issuing, and again reordering of limited list of products. On a realistic bases inventory management is a difficult task, because in many countries possession of a poor inventory management system in the pharmaceutical supply system has resulted in wastage or blockade of financial resources, shortage and overage of essential drugs, increase in out-of-pocket expenditure and decline in quality of healthcare services. Objective: This study is undertaken to assess the pharmaceutical inventory management and store keeping practices followed at the rural primary health centers in Udupi district, Karnataka. Methods: Retrospective data was collected by conducting a situational analysis in selected 20 primary health centers located across Udupi district. The collected data is related to the system of inventory management adopted, procurement practices, purchasing documents, essential drug lists, stock records, rate of correct items received and supplied, rate blacklisted and expired drugs, and rate of drug storages. The key performance indicatorswere collected from 2013 to 2015 to study the system and to identify the existing bottlenecks. Results: The inventory management and store keeping system implemented in primary health care (rural division) is still a piecemeal and ad hoc in nature. With the provided infrastructure, work force, complex procedures, manual system of record maintenance, lack of co-ordination between the activities and players only causes plethora of bottlenecks resulting in irrational usage of limited resources. Conclusion: Overall, there are still chances for improvement within the public pharmaceutical supply system at the primary healthcare level in the state. If corrective standardized measures are implemented in the areas of procurement, drug quantification, distribution, and inventory control, then the problems associated with stock-outs and wastage can be minimized. Key words: Drug inventory control, Stock management, Primary health centers in Karnataka, Pharmaceutical storage, Drug supply and distribution.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"1 1","pages":"53-59"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72825335","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}

{"title":"Development and Characterization of Fast Dissolving Tablet of Diflunisal by Solid Dispersion Method","authors":"R. Tiwari, S. Singh, Poonam Kushwaha, S. Usmani","doi":"10.5530/PHM.2015.6.8","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.8","url":null,"abstract":"Aim and Objective : Solubility is the important physicochemical factors which affect the absorption of drug and therapeutic effectiveness. The poor solubility of drug substance in water and low absorption in aqueous GIT fluid leads to insufficient bioavailability. The purpose of present research work is to increase the aqueous solubility and dissolution rate of poorly water soluble drug. Materials and Methods : Solubility of diflunisal enhanced by solid dispersion (kneading method) method using beta cyclodextrin as a carrier (also act as taste masking agent). Fast dissolving tablet of diflunisal was prepared by direct compression method using crospovidone as a superdisintigrant from optimized solid dispersion complexes. Prepared tablets were evaluated for various parameters: weight variation, hardness, friability, modified dispersion time, disintegration test, drug content and drug release. Results and conclusion: From the results obtained it has been concluded that prepared tablets from formulation F3 which contain 5% crospovidone as a superdisintigrant showed high dissolution rate and good flow property than other tablet prepared from solid dispersion. Key words: Fast dissolving tablet, Diflunisal, Solid dispersion, β cyclodextrin, Direct compression, Crospovidone.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"14 1","pages":"60-66"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90614212","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}

{"title":"Formulation, Optimization and Characterization of Solid Dispersion of Glibenclamide","authors":"N. Dhillon, K. Midha, M. Nagpal, R. Pahwa","doi":"10.5530/PHM.2015.6.10","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.10","url":null,"abstract":"Aim: The aim of the present study was to increase the solubility and dissolution of Glibenclamide. Materials and Methods: Various batches of solid dispersion of Glibenclamide using water soluble carriers such as PEG (PEG 4000 and PEG 1500), were prepared as per the design expert (8.0.5) to optimize the drug release profile using response surface methodology (Face centered central composite design). Results: DSC and FTIR were used to characterize the solid dispersions. No chemical interaction was found between Glibenclamide and polymers. F3 and F13 was found to be optimized batch according to the Face centered central composite design (FCCCD). Conclusion: Drug release was directly proportional to the concentration of polymer used for the formulation of solid dispersion. Thus, Glibenclamide with PEG 4000 and PEG 1500 had faster dissolution rate than Glibenclamide itself. Key words : Solid Dispersion, Dissolution, Physical Mixture, Polyethylene Glycol.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"72 1","pages":"72-81"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85581137","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}

{"title":"Development and Validation of UV Spectroscopic Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form","authors":"Ishpreet Kaur, S. Wakode, H. Singh","doi":"10.5530/PHM.2015.6.11","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.11","url":null,"abstract":"Objective: To develop and validate simple, sensitive, precise, rapid and cost effective method for determination of Canagliflozin in bulk and pharmaceu tical formulations as per ICH Guidelines. Methods: A simple double beam UV Spectrophotometric method has been developed and validated with different parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness and Rug gedness. Results: Canagliflozin in methanol shows maximum absorbance at 290 nm. Beer’s law was obeyed in the concentration range of 5-10 mcg mL1, The LOD and LOQ were found to be 0.084 mcg/ml and 0.255 mcg/ml respectively. A recovery of Canagliflozin in tablet formulation was observed in the range of 80.00-120.00%. Percentage assay of Canagliflozin tablets (INVOKANA ® ) was found to be more than 99%. Conclusion: The proposed","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"19 1","pages":"82-86"},"PeriodicalIF":0.0,"publicationDate":"2015-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91221257","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}

{"title":"New Spectrophotometric Methods for the Simultaneous Determination of Irbesartan and Hydrochlorothiazidein Combined Dosage Forms","authors":"J. Kumar, M. M. Annapurna","doi":"10.5530/PHM.2015.6.18","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.18","url":null,"abstract":"The combination of Irbesartan and Hydrochlorothiazideis mainly used for the treatment of hypertension. New spectrophotometric methods have been developed and validated for the simultaneous determination of Irbesartan and Hydrochlorothiazide in pharmaceutical formulations (Tablets) by two methods i.e. simultaneous equation method and absorbance ratio method (Q‐analysis) in phosphate buffer (pH 7.5). Irbesartan and Hydrochlorothiazide have shown linearity over the concentration range 5-35 μg/ml and 0.2-40 μg/ml in both the methods. Key words : Hydrochlorothiazide, Irbesartan, Spectrophotometric, Tablets, Validation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"16 1","pages":"120-125"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88835812","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}

{"title":"A New Validated Stability Indicating Liquid Chromatographic Method for the Determination of Agomelatine","authors":"M. M. Annapurna, B. Venkatesh","doi":"10.5530/PHM.2015.6.20","DOIUrl":"https://doi.org/10.5530/PHM.2015.6.20","url":null,"abstract":"Agomelatine is a melatonergic anti-depressant. A stability-indicating high performance liquid chromatographic technique was developed for the determination of Agomelatine in pharmaceutical formulations. Chromatographic separation was achieved on Shimadzu Model CBM-20A/20 Alite, using Zorbax extended-C 18 column (150 mm × 4.6 mm i.d., 5 µm particle size) with a mixture of 0.1% ammonium formate and acetonitrile (40:60, v/v) as mobile phase with a flow rate of 0.8 ml/min. Agomelatine was subjected to stress conditions such as acidic, alkaline, oxidation photolytic and thermal degradations and the method was validated as per ICH guidelines. Key words: Agomelatine, RP-HPLC, Validation, Stability-indicating.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"15 1","pages":"130-136"},"PeriodicalIF":0.0,"publicationDate":"2015-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89017750","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}