Development and Validation of RP-HPLC method for determination of Minacipran Hydrochloride for Pharmaceutical formulations

Abstract

A sensitive, isocratic RP‐HPLC method was developed for the determination of Milnacipran hydrochloride in bulk drug and its pharmaceutical capsule formulations where the mobile phase optimized was phosphate buffer: acetonitrile (72:28 v/v) with C18 column as stationary phase. The flow rate and detection wavelength was 1.0 mL min‐1 and 220 nm respectively. The developed method was validated as per ICH guidelines for specificity, linearity and range, precision, accuracy, robustness, solution stability, limit of quantification, and limit of detection and. The results of all the validation parameters were well within their acceptance values also the degradation products formed during the different stress conditions in specificity studies were separated from Milnacipran hydrochloride and also from individual degradation products. The method gave good recovery in the range of 99.1‐101.0 % for Milnacipran hydrochloride when it was applied for its determination in pharmaceutical capsule formulations.