Development and Validation of UV-Spectrophotometric and Stability Indicating RP-HPLC Method of Calcipotriene in Bulk Drug and Pharmaceutical Formulation

The objective of current study was to develop and validate stability indicating UV Spectrophotometric and RP-HPLC method for Calcipotriene in bulk drug and pharmaceutical formulation. UV Spectrophotometric method was developed utilizing Analytical Technologies limited. Detection was carried out at absorption maxima at 260nm using methanol as a solvent. Beer's law was followed in the concentration range of 5-25 µg/mL, and the drug was quantitated using A1% 1cm at 260 nm, which produced a correlation coefficient that was less than 1. The Chromatographic separation of analyte was achieved on Agilent C18 (4.6mm x 250mm, 5µm) column with mobile phase consisting of Methanol and 0.1 % Acetic Acid in the ratio of 65:35% v/v at flow rate of 1.0 ml/min. The retention time was found to be 5.273 min. Calcipotriene was subjected to forced degradation studies under different stress conditions like acid hydrolysis, alkaline hydrolysis, and hydrogen peroxide oxidation. The developed method was validated according to the guidelines of International Conference on Harmonization (ICH) for various parameters like linearity, precision, accuracy, robustness, limit of detection and limit of quantitation. The findings showed that the method performed well in accordance with the standards. The proposed method is simple, accurate, precise, economic, reproducible and stability indicating and hence suitable for routine quality control analysis of Calcipotriene in bulk drug as well as in formulations.