DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY FOR GRISEOFULVIN BY RP-HPLC IN TABLET DOSAGE FORM
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 Ã— 4.6 mm i.d., 5Î¼ 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 0.1-1.2Î¼g/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
Griseofulvin. Available from: http://en.wikipedia.org/ wiki/ griseofulvin. [last accessed on 28th Aug 2012].
Bo W, Dong L, Theodore RB. Development and validation of a HPLC method to determine griseofulvin in rat plasma: application to pharmacokinetic studies. Anal Chem Insights 2008;3:103-9.
Edward T, Paul R. High-performance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: separation of impurities and metabolites. J Pharm Sci 1980;69:523-6.
Pradhan KK, Mishra US, Mishra D, Sahu KC. Method development validation and stability of griseofulvin by UV spectrophotometric method. Inventi Rapid Pharm Analysis Quality Assurance 2011;212:100-5.
Shete AS. Formulation and evaluation of hydrotropic solubilization based suspensions of griseofulvin. Int J Pharm Sci Res 2010;1:51-7.
Green JM. A practical guide to analytical method validation. Anal Chem 2001;68:305A-9A.