VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ASSAY OF FUSIDIC ACID, BETAMETHASONE-17 VALERATE AND CHLOROCRESOL CONTENT IN TOPICAL PHARMACEUTICAL FORMULATION
Journal Title: Int J of Pharm Res & Analy - Year 2015, Vol 5, Issue 2
Abstract
A new stability indicating reversed phase HPLC method was developed and validated for assay of fusidic acid, betamethasone -17 valerate and Chlorocresol in Topical pharmaceutical formulation. The chromatographic separation was achieved on Lichrospher RP-18 125 mm x 4.0mm, 5 μm column ,Using a mobile phase comprising of mixture of Acetonitrile, Methanol and 0.05M Ortho-Phosphoric acid in the ratio of 50:5:45 (v/v), at a flow rate of 1.5 ml/min. Injection volume 10 μL, The column temperature was set at 25°C. The detection was carried out at 235 nm. The precision of the method observed in RSD is 0.5 %, 0.7 % and 0.4 %, The Overall RSD of Method Precision and Intermediate Precision are 0.9 %, 1.7 % and 2.3 % , Individual % recovery values observed in the range of 96.1 % to 101.6 %, 96.9 % to 103.9 % and 91.8 % to 99.4 % for Fusidic acid, Betamethasone-17 valerate and Chlorocresol respectively. Sample solution is observed to be stable at least 36 hours at room temperature. The method is found to be robust under the following variable conditions like flow + 10%, column oven temperature + 5°C, organic content in mobile phase + 2%, and wave length + 5 nm. The linearity of response was determined in the range of 289.96 μg/mL to 942.38 μg/mL for Fusidic acid, 19.01 μg/mL to 61.77 μg/mL for Betamethasone-17 valerate and 15.95 μg/mL to 51.85 μg/mL for Chlorocresol, the Correlation coefficient is 0.99886, 0.99898 and 0.99884 respectively. Significant degradation was observed during the Forced degradation studies, in drug product and placebo were exposed to 40°C / 15 minute in hydrolysis Acid, Alkali 1 N NaOH , Peroxide 30 %w/w of Hydrogen peroxide and thermal (105°C / 24 hours 7 minutes) ,photolytic degradation ( 321929 Lux hours & 97.02 Watt hours / sq. m at 25 °C).
Authors and Affiliations
Pankaj Sharma , Sudhakar P* , Birendra Shrivastava1
Keywords
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- EP ID EP127996
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