Method development and validation for determination and quantitative estimation of impurities in milnacipran hydrochloride by liquid chromatography technique

Kanchan Nautiyal and K. Ramakr

Abstract

The present paper describes a simple gradient reverse phase Chromatographic method for the quantification of organic impurities in Milnacipran (MCP). Detection ,estimation and good quality resolution was achieved between Milnacipran and Nine impurities using C18 (100mm×4.6mm,2.7μ) column using a gradient elution pattern with buffer of Octane -1-sulphonic acid and solvent as Acetonitrile and Methanol at a flow rate was 1.0 ml/min and the detection was carried out at 210nm. The factors involved in the method development were discussed. The method was validated as per International Conference on Harmonization (ICH) guidelines in terms of specificity, system suitability, precision, accuracy, linearity and was able to quantitate all the nine impurities. The method was able to quantitate up to 0.404 ppm of Imp-1, 0.398 ppm of Imp-2, 0.474 ppm of Imp-3, 0.407 ppm of Imp-4, 0.400 ppm of Imp-5, 0.402 ppm of Imp-6, 0.401 ppm of Imp-7, 0.398 ppm of Imp-8, 0.404 ppm of Imp-9 and 0.407 ppm of Milnacipran