Stability-Indicating HPTLC Method for Determination of Milnacipran Hydrochloride in Pharmaceutical Formulations

Abstract

A simple, specific, precise and accurate stability-indicating assay method using high performance thin-layer chromatography (HPTLC) is described for estimation of Milnacipran hydrochloride (MIL) in bulk drug and in pharmaceutical formulations. The sepa rations were achieved on prepared TLC plates precoated with silica gel 60 F254. The mobile phase developed and optimized for bringing out the separation involves chloroform–methanol–ammonia in the ratio of 6.4:2.5:0.2 v/v/v. The densitometric scanning wavelength selected was 220 nm. The compact bands of MIL were obtained at RF value of 0.45 ± 0.02. The method developed was able to separate peaks of all the degradation products formed in ICH-prescribed stress conditions with sufficient difference in their RF values. The developed method was validated for linearity and range, specificity, precision, accuracy and robustness, and the results were found to be within acceptance criteria. The reliability of the method was evalu ated when it was applied for the estimation of MIL in pharmaceuti cal capsule formulation, and assay results gave good recovery when statistically compared with the reversed-phase high-performance liquid chromatography (RP-HPLC) method.