Development and Validation of Analytical Methods for Estimation of Cardiovascular and Antidiabetic Drugs in Pharmaceutical Formulations

Abstract

Reverse phase chemistry for new chromatographic methods of analysis with newlinesimple step sample preparation techniques having precise and accurate results within newlinethe pre-defined acceptable criteria were developed for simultaneous assay newlinedetermination of Dapagliflozin and Saxagliptin, Nebivolol and Valsartan, Sacubitril and newlineValsartan and for Sitagliptin, Metformin and Empagliflozin as well as for the estimation newlineof impurity content of Empagliflozin, Valsartan and Nebivolol in bulk and newlinepharmaceutical dosage form. newlineThe chromatographic separation with reverse phase chemistry was achieved newlinebetween Nebivolol, Valsartan, Impurity C of Nebivolol and Desvaleryl Impurity of newlineValsartan to accurately quantify the impurity contents. Impurity D and Sugar Dimer newlineimpurity of Empagliflozin are well separated from each other as well as from newlineEmpagliflozin analyte peak and to estimate the impurity contents. The separation newlinealong proper resolution between selected drug substance components was achieved in newlineabove mentioned respective dosage forms to determine the assay by chromatographic newlinetechnique. newlineThe developed assay and related substances methods are confirmed by newlineperforming validation as per the parameters mentioned in ICH guideline of analytical newlinemethod validation for specificity, system suitable testing, linearity, range, accuracy, newlineprecision, quantitation limit, robustness and forced degradation study. The results of newlinevalidation parameters performed are within the acceptable criteria. The drug product newlinesamples were subjected to predefined stress conditions to check the stability indicating newlineability of the methods of analysis. Degradation studies of the samples were carried at newlineacidic, basic, oxidative, heat and photostability conditions. The results obtained newlineproved the ability of analytical methods to determine the contents as well as impurities newlinepresent in the sample to detect the changes during the stability of the respective drug newlinesubstances in the marketed formulation product. newlineThe methods are applied to the analysis of respective available and selected newline