DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY FOR GRISEOFULVIN BY RP-HPLC IN TABLET DOSAGE FORM
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 3
Abstract
Objective: To development and validation of a stability indicating reverse phase HPLC (RP-HPLC) method for the analysis of griseofulvin, an antifungal drug, and its assay method, in tablet dosage forms.Methods: The proposed RP-HPLC method utilizes Shiseido C18, 250 mm × 4.6 mm i.d., 5μ column (at ambient temperature), isocratic run [using Methanol and Water (70:30) as mobile phase], at a flow rate of 1.0 ml/minute, and UV detection at 291 nm for analysis of griseofulvin. This method was selected after applying different chromatographic conditions, the chromatographic variables like flow rate, the composition of mobile phase and nature of stationary phase were studied.Results: The reported method is linear over the range of 0.1-1.2μg/ml with a coefficient of correlation (r2) value 0.9998, slope 274.9 and intercepts 19093. The precision study revealed that the percentage relative standard deviation was within the acceptable limit and the mean recovery was found to be between 98%-102%. Griseofulvin was exposed to acidic, alkaline, oxidative, thermal and photolytic stress conditions and the sample was taken at different time intervals. The stressed samples were analyzed by the proposed method. The proposed method can be used for routine analysis stability testing and assay of griseofulvin in quality control laboratories.Conclusion: An economical, accurate, sensitive and precise HPLC method with ultraviolet detection was developed and fully validated for quality control analysis of griseofulvin in tablets. The proposed method is very rapid, where the total analytical run time is 5.16 minute.Keywords: RP-HPLC, Method validation, Griseofulvin, Estimation
Authors and Affiliations
Shilpi Pathak, G. P. Agrawal, Prof. Pradeep Mishra
Keywords
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