Pharmaceutical Methods最新文献

{"title":"Development and Characterization of Buccal Film of Candesartan","authors":"Dipak Rajaram Malpure, S. Deore","doi":"10.5530/PHM.2016.7.12","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.12","url":null,"abstract":"Candesartan is potent antihypertensive drug of class angiotensin II receptor antagonist. But it exhibits poor water solubility and extensive first pass metabolism. Present research deals with development of candesartan buccal film. Optimisation of buccal film was done by design expert. Optimised concentration range selected for development of trial batches of candesaratanbuccal films. Mucoadhesivebuccal films of candesartan were prepared by solvent casting technique using chitosan, HPMC, gelatin and EDTA as permeation enhancer. Prepared buccal films evaluated for various pharmaceutical parameters, stability studies, in-vitro and ex-vivo evaluation parameters performed. In-vitroangiotensin II receptor antagonist studies were also performed. Results showed improved bioavaibility of candesartan through buccal films. Keywords: Candesartan, Angiotensin II receptor antagonist, Buccal film, Box-Behnken desig. Mucoadhesive strength.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"24 1","pages":"75-88"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84238466","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":"Effect of Different Diffusion Membranes on the Diffusion Rate of Niacinamide and Diclofenac Sodium From Topical Formulations","authors":"R. Suriyanarayanan, H. Shivakumar, N. Shivanandappa","doi":"10.5530/PHM.2016.7.14","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.14","url":null,"abstract":"The aim of the study was to correlate diffusivity of Niacinamide from a cream formulation and Diclofenac sodium from a gel formulation. Evaluation is done by in vitro drug release through Franz diffusion cell and different diffusion membranes. The membranes used for the study were Polytetrafluoroethylene (PTFE), Polyvinylidene fluoride (PVDF) and Dialysis membranes. Phosphate buffer pH 5.5 was the receptor medium. Studies showed significant variations in the diffusion rate of niacinamide and Diclofenac sodium across different membranes. The percentage of Niacinamide diffused from niacinamide cream after 120 min was found to be PTFE (1.5%), PVDF (54.15%) and Dialysis membranes (21.6%). The percentage of diclofenac sodium diffused from diclofenac gel after 180 min was found to be PTFE (2.42%), PVDF (14.42%) and Dialysis membranes (9.8%). From the study it was concluded that membranes having different characteristic property shows different diffusivity. Therefore interpretation of in vitro diffusion data to correlate with in vivo dermal penetration need further in-depth study. Key Words: Polytetrafluoroethylene (PTFE), Polyvinylidene fluoride (PVDF), Diclofenac sodium, Dialysis membrane, Niacinamide.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"11 1","pages":"94-98"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91503268","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 Analytical Method Development and Validation of Ciprofloxacin and Ornidazole in Human Plasma by High Performance Thin Layer Chromatography","authors":"A. R. Rote, R. Saudagar","doi":"10.5530/PHM.2016.7.13","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.13","url":null,"abstract":"Objective: The objective of the method was to develop a simple, rapid, sensitive, selective and economic high performance thin layer chromatographic method for simultaneous determination of ciprofloxacin and ornidazole in human plasma by using tinidazole as an internal standard. Method: The plasma sample was extracted using methanol: formic acid (5.5:0.5 v/v) and known amount of extract was spotted on precoated silica gel 60 F 254 plates using Camag Linomat V auto sampler. A concentration range from 100–700 ng/spot for both drugs was used for calibration curve. The percent recoveries of Ciprofloxacin and ornidazole were found to be 81.02 to 86.26 and 79.73 to 82.16 respectively. The mobile phase used consists of chloroform: methanol: triethylamine (9.0: 0.8: 0.4 v/v/v). Densitometric analysis was carried at wavelength 291 nm. Result: The R f values for ciprofloxacin, ornidazole and tinidazole were found to be 0.18 ± 0.057, 0.49 ± 0.0.0057 and 0.75 ± 0.0054 respectively. The stability of ciprofloxacin and ornidazole in plasma were confirmed during three freeze-thaw cycles (-20oC), on bench during 12 h and post preparative stability study. The proposed method was validated statistically by performing recovery study for determination of ciprofloxacin and ornidazole in human plasma. Conclusion: The proposed method was found to be a simple, rapid, sensitive, selective and economic high performance thin layer chromatographic method for simultaneous determination of ciprofloxacin and ornidazole in human plasma In future this method can be used for clinical and pharmacokinetic studies. Key words: Ciprofloxacin, Ornidazole, HPTLC, Human plasma, Liquidliquid extraction.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"35 1","pages":"89-93"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81915921","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":"Design and Evaluation of Ophthalmic Delivery of Bepotastine Besilate From Eye Drop","authors":"Sonali S. Askarkar, K. Gupta","doi":"10.5530/PHM.2016.7.16","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.16","url":null,"abstract":"Introduction: The purpose of present study was to design and evaluate bepotastine besilate ophthalmic solution 1.5% to develop a stable formulation using buffering agent, tonicity modifier and preservative. Method: In this study the concentration of preservative and tonicity modifier concentration are adjusted in such a way so that the final formulation will have least concentration of preservative still it will be protected from microorganisms and isotonic so that after instillation when formulation will come in contact with tissues there should not be any swelling, contraction or discomfort. Result: The preservative content was selected in the range of 0.002– 0.012% and tonicity modifier in the range of 0.45–0.9%. Bepotastine besilate ophthalmic solution 1.5% filled in LDPE container having fill volume 5 mL is clear, colourless solution having pH range 6.8–7.0, drop size of 38.6 μl and % water loss after 3 months as 1.9748%. The percent purity of bepotastine besilate and preservative was determined using RP-HPLC method was found to be 100.50 and 51.648% with % RSD as 0.84 and 0.65% respectively. The samples of the formulation also subjected to stability as per ICH guidelines and 6 months data was generated. Draize test protocol was also followed to study invivo eye irritancy of the formulation to produce a safe and effective formulation. Conclusion: Laboratory prepared formulation of bepotastine besilate ophthalmic solution 1.5% has showed good stability at both 25°C and 40°C as the drug and preservative content was within the accepted range. Key words: Bepotastine besilate, Benzalkonium chloride eye drop, Preservative, Ophthalmic preparation, Stability study, Isotonicity.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"142 1","pages":"104-111"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88989258","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":"Gas Chromatographic Method for Analysis β-Asarone in Rhizome extracts of Acorus calamus and Their Microbiological Evaluation","authors":"K. Vijayakumar, G. Bannimath, V. S. Koganti, V. Iyer","doi":"10.5530/PHM.2016.7.18","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.18","url":null,"abstract":"Introduction: The aim of study was to develop a simple, sensitive and precise gas chromatographic method for the analysis of β-asaronein ethanolic, ethyl acetate, aqueous extracts from the rhizomes of Acorus calamus and validate according to current ICH guidelines. Followed by evaluation of antimicrobial activity of prepared extracts in comparison with penicillin disc. Methods: The β-asarone was one chief active constituent from the rhizomes of Acorus calamus. The ethanolic, ethyl acetate, aqueous extract of rhizomes was prepared and further evaluated for its antimicrobial activity against Streptococcus Mutants by agar well diffusion method. The GC method was used for the analytical determination of β-asarone. The sample was estimated using gas chromatography with flame ionization as a detector. Nitrogen at a flow rate of 1.18 mL/min was used as a carrier gas and total run time was 10 minutes. The injection port and detector temperature were set to 225˚C and 270˚C, respectively. The retention time of β-asarone was found to be 6.9 minutes. Results: The linearity of the developed method was tested in the range of 100 ng/mL-500 ng/mL for β-asarone, limit of detection and limit of quantification was found to be 22.78 and 69.05 ng/mL respectively and the percentage recovery was from 99.63- 100.64%. Conclusion: A simple, precise and accurate GC-FID method has been developed for the determination of β-asarone in ethanolic, ethyl acetate and aqueous extracts of rhizomes. Key words: Acoruscalamus , β-Asarone, Alcoholic, Aqueous, Ethyl acetate, Extracts, GC- FID, Microbiological evaluaiton, Stability studies.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"46 1","pages":"121-126"},"PeriodicalIF":0.0,"publicationDate":"2016-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85463860","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":"Stability-indicating UFLC method for uncoupling and estimation of impurities in clopidogrel, aspirin and omeprazole in their tablet dosage form using PDA detection","authors":"J. B. Nagavi, B. Gurupadayya","doi":"10.22034/IJPS.2016.22801","DOIUrl":"https://doi.org/10.22034/IJPS.2016.22801","url":null,"abstract":"In this paper a fast and novel stability-indicating ultra fast LC method for separation and estimation of impurities in clopidogrel and aspirin in their combined tablet dosage form and omeprazole was developed. The separation of USP related substances of clopidogrel (A, B and C), aspirin (D), omeprazole (A, B and C) and few other unknown impurities was detected by using ultra fast liquid chromatography with PDA detection. The maximum detection was set as follows: 237 nm for aspirin, its impurities and for the impurity C of Clopidogrel and 254 nm for Clopidogrel and its impurities except for impurity C and 280 nm for omeprazole and its impurities. Phenomenex C8 (250 mm × 4.6 mm, 5μ) was used as a stationary column to separate and analyze the mixture within 11 min with a programmed gradient elution of 0.01 M phosphate buffer pH 2.0 and acetonitrile. The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for clopidogrel and its impurities, aspirin and its impurity D and omeprazole and its impurities A, B and C. The tablets were exposed to acid, alkaline, thermal, higher humidity, oxidative and photolytic stress conditions. Samples undergone stressed conditions were analyzed by the novel proposed method. Separation was satisfactory for all the significant degradation products from the principal peaks of drug substances and the impurities from each other. The method complies for the peak purity test for clopidogrel, aspirin and omeprazole in all the samples under stress and showed no co-elution of degradation products. The method was found to be stable, precise, linear, accurate, sensitive, specific and robust. The method can be used routinely to test the adulteration in the pharmaceutical formulations of clopidogrel, aspirin, and omeprazole.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2016-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74389466","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":"Effect of sample Concentration on the Characterization of Liposomes using Dynamic light Scattering Technique","authors":"Ramesh Surianarayanan, H. Shivakumar, Nagavalli Vegesna, A. Srivastava","doi":"10.5530/PHM.2016.7.11","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.11","url":null,"abstract":"Objective: The objective of the study was to assess the effect of liposomal concentration on the characterization of liposome using dynamic light scattering technique. Method: Liposome of a water soluble active, Niacinamide, was taken for the study. Phospholipid combination (INCI name lecithin and Propane diol) was used to form liposomes of Niacinamide. Concentrated liposomal suspension was prepared using various ratios of phospholipid. The concentrated liposomal suspension was diluted five times using distilled water. Concentrated liposomal suspension and diluted suspension were characterized for particle size, PDI, conductivity and Zeta potential. Their surface morphology was studied with SEM images. Results: The data on conductivity, PDI, zeta potential and particle size were significantly different between concentrated and diluted liposomal samples. The use of various phospholipid ratios appears to significantly affect PDI, zeta potential and particle size in concentrated sample. The data on diluted samples indicated that the phosholipid level has no significant effect on these parameters. Conclusion: In conclusion, characterizing liposomes using techniques which involves dynamic light scattering, that is widely used, liposome concentration during measurement is important to get reliable results. Key words: Liposomal dilution, Niacinamide, Polydispersity index, Particle size.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"9 1","pages":"70-74"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81679073","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":"HPTLC Method Development and Validation of Cilnidipine and Metoprolol Succinate in Combined Dosage Form","authors":"Dhwani K. Desai, Nirmal Vashi, H. Dalvadi, Shuchi H. Desai, M. Hinge","doi":"10.5530/PHM.2016.7.5","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.5","url":null,"abstract":"Introduction and Objectives: The present work involves development and validation of HPTLC method for simultaneous estimation of Cilnidipine and Metoprolol Succinate in their combined tablet dosage form. Method: In HPTLC method, Silica Gel G60 F254 TLC plate as the stationary phase and a mobile phase of Toluene: Chloroform: Methanol: Glacial acetic acid (45: 25: 25: 5 v/v/v/v) was used to resolve CIL and METO. CIL and METO were quantified at 231 nm. The proposed method weas validated according to International Conference on Harmonization. Result and Discussion: Two well-separated and sharp peak for CIL and METO were obtained at Rf values of 0.70 ± 0.01 and 0.34 ± 0.005 respectively. The linearity range obtained for HPTLC method were 100-500 ng/spot and 500-2500 ng/spot for CIL and METO respectively. Conclusion: Method validation was found to be accurate, specific and precise.The developed method was successfully applied for estimation of CIL and METO in combined tablet formulation. Key words: Cilnidipine, Metoprolol succinate, HPTLC, Tablets, Simultaneous estimation, Method validation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"21 1","pages":"28-34"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89144478","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 Stability indicating UV Spectroscopic Method for Determination of Canagliflozin in Bulk and Pharmaceutical Dosage Form","authors":"Ishpreet Kaur, S. Wakode, H. Singh","doi":"10.5530/PHM.2016.7.10","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.10","url":null,"abstract":"Objective: To develop and validate simple, definite, stability indicating UV spectroscopic method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Q2 R1 Guidelines. Methods: Canagliflozin was subjected to different stress conditions as per ICH guidelineQ1A (R2). A stability-indicating UV Spectrophotometric method has been developed for analysis of the drug in the presence of the degradation products and is validated with different parameters such as Linearity, Precision, Repeatability, Limit of Detection (LOD), Limit of Quantification (LOQ), Accuracy, Robustness and Ruggedness. It involved a 2-h study in which methanol and distilled water were used as solvents. Results: Canagliflozin in methanol shows maximum absorbance at 290 nm. Beer’s law was obeyed in the concentration range of 5-10 mcg/mL. 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%. Degradation of Canagliflozin was found to occur in acid, alkaline, hydrogen peroxide and photolytic conditions where as it was found to be thermally stable. The amount of degraded drug was calculated by taking absorbance at 290 nm. Conclusion: The proposed method is definite, meticulous, reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form. Key words : Canagliflozin, Method development, Validation, Ultraviolet Spectroscopy, Forced degradation.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"9 1","pages":"63-69"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86230439","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 of Cefpodoxime Proxetil and Azithromycin Dihydrate in Pharmaceutical formulation","authors":"M. Hinge, Malini Manojbhai Bhavsar, R. Singh, R. Chavda, Ekta S. Patel, D. Patel","doi":"10.5530/PHM.2016.7.2","DOIUrl":"https://doi.org/10.5530/PHM.2016.7.2","url":null,"abstract":"Introduction: UV spectrophotometric methods and High performance liquid chromatographic method were developed for the determination of the Cefpodoxime Proxetil and Azithromycin Dihydrate in tablet form. Methods: In UV Simultaneous equation method and Absorbance ratio method were used. The wavelength of maximum absorbance 232.40 nm for Cefpodoxime Proxetil and 218 nm for Azithromycin Dihydrate are used in simultaneous equation method and 220.60 nm (isoabsorptive point) and 232.40 nm (λ max of Cefpodoxime Proxetil) are used for absorbance ratio method. A simple liquid chromatographic assay has been developed for the determination of Cefpodoxime Proxetil and Azithromycin Dihhydrate. A C 18 (150×4.6 mm, 5 μm) column was used with a mobile phase consisting of Acetonitrile: Methanol: Phosphate buffer (40:40:20 v/v) at a flow rate of 1.0 ml min -1 . Quantitation of both drugs was achieved by using UV detector at 235 nm. Results : Calibration curves were linear in the range of 8-40 μg/ ml for Cefpodoxime Proxetil and 10-50 μg/ml for Azithromycin Dihydrate in absorbance ratio method. Accuracy for both the drugs was in the range of 98-101%. The retention time for Cefpodoxime Proxetil and Azithromycin Dihydrate was found to be 6.14 and 2.95 respectively. Beer’s law was obeyed in a concentration range of 20-100 μg/ml for Cefpodoxine Proxetil and 25- 150 μg/ml for Azithromycin Dihydrate and the regression line equation was derived with a correlation coefficient of 0.9984 and 0.9978 for Cefpodoxime Proxetil and Azithromycin Dihydrate respectively. The method was validated according to ICH guidelines for various parameters like accuracy, precision, specificity, linearity, robustness, LOD and LOQ. Discussion: The proposed procedures were successfully applied to the determination of Cefpodoxine Proxetil and Azithromycin Dihydrate in tablet form, with high percentage of recovery, good accuracy and precision. Key words: Cefpodoxime Proxetil, Azithromycin Dihydrate, Simultaneous equation method, Absorbance ratio method, HPLC, Tablets.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"12 1","pages":"8-16"},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78162920","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}