Validation of a Stability Indicating LC Method for Amiodarone HCL and Related Substances

Abstract

A simple, rapid and sensitive isocratic high performance liquid chromatographic (HPLC) method has been developed for the estimation of purity and quantitative determination of Amiodarone HCl active pharmaceutical ingredient (API).The method describes a quantitative estimation of five process related impurities of Amiodarone HCl with a resolution of more than or near to 3.0 between each impurity. These five known related substances are estimated by a simple, rapid and accurate reverse phase isocratic HPLC method. The method has been validated for the determination of assay and related substances in Amiodarone HCl API, using a C8 column. The elution is carried out using a mobile phase consisting of water-methanol-acetic acid with a pH 5.8. For the quantitative determination of these relative substances, a relative response factors have been determined for all five related substances with respect to Amiodarone HCl. The precision (system precision, method precision and intermediated precision) is demonstrated for both the assay as well as related substances on six independent sample preparations. Accuracy of the method (recovery) is demonstrated for both Amiodarone and each of the five related substances. Specificity of the method is demonstrated by forced degradation study of Amiodarone HCl API under various stress conditions. The method is found to be stability indicating and useful for the analysis of assay and related substances of Amiodarone HCl API in a routine quality control laboratory and for the stability studies of drug substance.