A simple precise NP-HPLC method development and validation for simultaneous determination of Betamethasone Dipropionate and Calcipotriene in topical formulation. Chromatographic separation of drug was achieved on Inertsil Silica 100Aº (250×4.6mm, 3μ) column with mobile phase A n-Hexane, tetrahydrofuran and Ethanol in the ratio 95:5:2 v/v/v, respectively as mobile phase A and mobile phase B as n-Hexane, tetrahydrofuran, Ethanol and Isopropylalcohol in the ratio 65:8:2:25 v/v/v/v, respectively in gradient mode at flow rate of 1.2mL/min. Analytes were detected at 264nm. Linear response (r>0.999) were observed over a range of 1.171 μg/mL to 32.9 μg/mL and 0.017 μg/mL to 3.1 μg/mL for Betamethasone Dipropionate and Calcipotriene respectively. Stability indicating capability of developed method is established by analysing forced degradation samples in which spectral purity of Betamethasone Dipropionate and Calcipotriene along with separation of degradation products from analytes peak. The method was validated as per ICH guideline for specificity, linearity, accuracy, precision, LOD, LOQ, robustness, solution stability and suitable for the quantitative determination of Betamethason Dipropionate and Calcipotriene in topical dosage form and also for quality control in bulk manufacturing.
