Abstract

VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ASSAY OF FUSIDIC ACID, HYDROCORTISONE ACETATE AND POTASSIUM SORBATE IN TOPICAL PHARMACEUTICAL FORMULATION

Sudhakar P.*, Dr. Pankaj Sharma and Dr. Birendra Shrivastava

ABSTRACT

This RP-HPLC method was successfully validated per ICH guidelines and proved to be suitable for routine quality control use. The chromatographic separation was achieved on Kromasil C18, 5 μm (150 mm x 4.6 mm) column, Using mobile phase gradient flow (ortho phosphoric acid buffer solution as solvent-A and acetonitrile as solvent-B), at a flow rate of 2.0 ml/min. Injection volume 10 μL, The column was set at 30°C. Wavelength at 240 nm. The precision of the method observed in RSD is 0.8%, 0.8% and 0.8%, The Overall RSD of Method Precision and Intermediate Precision results are 0.9%, 1.0% and 1.9%, Individual % recovery values observed in the range of 98.9% to 101.7%, 98.1% to 101.4% and 96.6% to 106.9% for Fusidic acid, Hydrocortisone acetate and Potassium sorbate respectively. Sample solution is observed to be stable 27 hours at 5°C temperature. The method is found to be robust under the 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 for Fusidic acid, Hydrocortisone acetate and Potassium sorbate was determined in the range of 136.81 μg/mL to 254.08 μg/mL, 71.83 μg/mL to 133.39 μg/mL and 11.417 μg/mL to 34.250 μg/mL, the Correlation coefficient is 0.99907, 0.99927 and 0.99958 respectively. Significant degradation was observed during the Forced degradation studies, in drug product and placebo. The peak purity test was complies using the PDA detector.

Keywords: Assay, Hydrocortisone Acetate, Potassium Sorbate, Fusidic Acid, HPLC, Topical Formulation.