Analytical Method Development And Validation Of The Test Method For Degradation Products Of Betamethasone Dipropionate In Betamethasone Dipropionate Cream 0.05% By Rp-Hplc Method

Abstract

A simple and rapid reverse – phase high performance liquid chromatographic method has been developed and validated for the force degradation studies of betamethasone dipropionate in betamethasone dipropionate 0.05% cream. The studies were carried out on a Waters e2695 Inertsil-ODS 3V 250×4.6mm, 5µm column with mobile phase A water, acetonitrile, tetrahydro furan, and methanol in ratio of 600:300:40:60 v/v/v/v and mobile phase B water and acetonitrile in ratio of 200:800 v/v respectively in gradient mode at flow rate of 1.5 mL/min. UV detection was performed at 240 nm. Linear response was observed between the acceptance criteria. Stability indicating capability of developed method is established by analyzing the forced degradation of betamethasone dipropionate 0.05% cream. The validation methods were performed as per the USP monograph for specificity, linearity, precision, LOD, LOQ, robustness, solution stability suitable for the quantitative determination of betamethasone dipropionate along with separation of degradation products from analytes peak. The retention time was 3.6min. The LOD and LOQ values was found to be 0.008 µg/ml and 0.024 µg/ml. The validated method is Specific, Linear, Precise, Accurate, Robust, Rugged and stability indicating for the determination of degradation products of Betamethasone dipropionate in Betamethasone Dipropionate cream USP, 0.05%.