Novel stability indicating UHPLC method development and validation for simultaneous quantification of hydrocortisone acetate, pramoxine hydrochloride, potassium sorbate and sorbic acid in topical cream formulation

Abstract

A stability indicating UPLC method has been developed successfully for Hydrocortisone Acetate, Pramoxine Hydrochloride, Potassium Sorbate and Sorbic Acid. The optimized UPLC method can be used for quantitation of Hydrocortisone Acetate, Pramoxine Hydrochloride, Potassium Sorbate and Sorbic acid in finished cream dosage forms. For the estimation of multi components in single method demands more comprehensive way of method development. The optimized UPLC method has been separated all major analytes with optimum resolution. The separation was acquired by using Acquity UPLC BEH column, C18, (150 × 2.1) mm, 1.7 µm particle size and maintained column temp 30 °C. Mobile phase-A contains 10 mM dibasic potassium phosphate (pH of 7.5) and acetonitrile (95: 5 v/v) and mobile phase-B was mixture of acetonitrile and water (90: 10 v/v). The estimation of Hydrocortisone acetate and Sorbate were carried out at 254 nm and for Pramoxine Hydrochloride at 225 nm in PDA detector. The entire chromatographic run time for separation was below 10 min. The curves presented correlation coefficient for three peaks was more than 0.999. Excellent precision and accuracy were obtained for Hydrocortisone acetate, Sorbate and Pramoxine Hydrochloride. Precision and intermediate precision, calculated as relative standard deviation, were lower than 2.2%. Recoveries differed from 97.5% to 102.4%. The drug product was subjected to the different stress conditions as per the current ICH guidelines. The developed stability indicating method approved for quantitative determination of Hydrocortisone Acetate, Pramoxine Hydrochloride, Potassium Sorbate and Sorbic Acid in cream formulations.