Development and Validation of a Robust RP-HPLC Method for Analysis of Calcipotriol in Pharmaceutical Dosage Form

Calcipotriol is a very efficient drug used in the treatment of psoriasis. In present work a novel, hasty, effortless and cost-effective Reversed -Phase High-Performance Thin-Layer Chromatography (RP-HPTLC) technique has been developed and subsequently validated for quantitative assessment of calcipotriol in bulk and in ointment. Optimized chromatographic condition was employed to accomplish separation on a Phenomenex Luna C18 column (250mm X 4.6 mm in diameter) with typical particle size of 5μ column employing Shimadzu HPLC system. Mobile phase constituting of methanol: water (80:20, v/v) was pumped during the chromatographic separation at 1 mL/min flow rate and detection was made by ultraviolet‑visible detector at 264 nm. The method was validated for linearity, precision, robustness, accuracy, limit of detection and limit of quantification as per guidelines of International conference on Harmonization (ICH). The method resulted into sharp and well resolved peak for Calcipotriol at 8.2 min retention time. Method was also found to be linear (regression coefficient: 0.999), accurate (average recovery: 100%), precise and robust. Thus the developed analytical method is acceptable for identification and quantitative estimation of calcipotriol in bulk formulation and ointment formulation.