Development and validation of stability indicating hplc method for the estimation of some combination of antidiabetic and antihypertensive drugs in their dosage form

Abstract

quotABSTRACT newline newlineDEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF SOME COMBINATION OF ANTIDIABETIC AND ANTIHYPERTENSIVE DRUGS IN THEIR DOSAGE FORM newline newlineSubmitted By: LEENA AJAY SAWAIKAR newlinePh.D. Scholar, RK University, Rajkot newline newlineSupervised By: Dr. PANKAJ KAPUPARA, newlineProfessor, newlineDepartment of Pharmaceutical Chemistry, newlineSchool of Pharmacy, newlineRK University, Rajkot newline newlineBackground: newlineThe major problem faced in the pharmaceutical industry today is the estimation of new drugs in combined bulk and dosage forms without any interference from any impurities. Diabetes and hypertension are a very common life style disorders prevalent globally. The present work describes simple, sensitive and selective analytical methods for the determination of antidiabetics and antihypertensives in combined dosage forms. newlineAim: newlineA. To develop and validate an RP-HPLC technique for the evaluation of Metformin hydrochloride and Teneligliptin hydrobromide hydrate and apply this technique for the evaluation of marketed formulation. newlineB. To develop and validate a stability indicating RP-HPLC technique for the newlineestimation of Chlorthalidone and Cilnidipine in a combined dosage form by carrying out forced degradation studies and applying the method for the estimation of marketed preparation. newlineTo identify the structures of generated degradants and establish the degradation pathway. newline newlineA. Materials and Methods: newlineChromatographic separation was achieved using HPLC model 1100 gradient system, C18 column with a mobile phase of Methanol: OPA (0.1%) in the ratio 55:45 v/v and flowrate of 1.0 mL/min and a detection wavelength of 241 nm for Metformin hydrochloride and Teneligliptin hydrobromide hydrate. The developed HPLC method was validated as per ICH guidelines. newlineResults and Discussion: The retention times were 2.897±0.2 minutes and 6.229±0.2 minutes and the mean assay results were 99.396 % and 102.940 % respectively for Metformin hydrochloride and Teneligliptin hydrobromide hydrate.