Development and Validation of the RP-HPLC Method for the Estimation of Chlorocresol and Betamethasone Dipropionate in Semisolid Dosage Formulation

Abstract

A simple, accurate, reproducible and cost-effective reverse phase HPLC technique for chlorocresol (CRC) as a preservative as well as betamethasone dipropionate (BTD) in bulk drug as well as semi-dose formulations. Snakes were developed during this research. In this method, Discovery HS (150x4.6 mm),was used as the stationary phase and an 80:20 mixture of water and isopropyl alcohol was used as the mobile phase A, and a mixture of acetonitrile plus tetrahydrofuran in the ratio. 70:30 ratio was used as mobile phase B in gradient mode to produce the final product. Approximately 1.00 ml/min of the solution is passed through the chromatograph by pumping it through. The UV detector operates at a wavelength of 240 nm. A validation study in accordance with the ICH Q2 (R1) guidelines is required to demonstrate that the new analytical method meets the reliability characteristics and these characteristics demonstrate the ability of a new analytical method. analysis in maintaining, over time, the basic validation criteria: selectivity, linearity, precision, precision, and specificity. When this method is used for quality control of commercial semi-solid dosage forms of betamethasone dipropionate throughout the day, the stability indicator technique can be used to measure the breakdown of the drug and its products it, as well as to evaluate the results of the tube homogeneity test.