Stability-Indicating LC Method for Assay of Cholecalciferol

This paper discusses the development of a stability-indicating reversed-phase LC method for analysis of cholecalciferol as the bulk drug and in formulations. The mobile phase was acetonitrile–methanol–water 50:50:2 (v/v). The calibration plot for the drug was linear in the range 0.4–10 μg mL⁻¹. The method was accurate and precise with limits of detection and quantitation of 64 and 215 ng, respectively. Mean recovery was 100.71%. The method was used for analysis of cholecalciferol in pharmaceutical formulations in the presence of its degradation products and commonly used excipients.