Abstract

Simultaneous determination of lisinopril and hydrochlorothiazide related impurities in lisinopril and hydrochlorothiazide combined tablet dosage forms using HPLC

Author(s): P.Aparna, Sumathi Rao, K.M.Thomas, K.Mukkanti

The present work describes a simple, sensitive and highly specific reverse phase high performance liquid chromatographic method for the simultaneous determination of impurities of lisinopril and hydrochlorothiazide fromtheir combined dosage form. SymmetryC18column and amobile phase comprising of 1-hexane sulphonic acid sodium salt, triethylamine, orthophosphoric acid, acetonitrile and methanol has been used for thismethod. developed method is selective for the impurities of lisinopril and hydrochlorothiazide. The validation elements investigated showed that the method has acceptable specificity, recovery, linearity, solution stability and method precision. Acceptable robustness indicates that this method remains unaffected by small but deliberate variations,which are described in ICH guidelines.