Development and validation of analytical method for selected active pharmaceutical ingredients and dosage form

Abstract

quotAim: Accurate, precise, robust, quick and simple however cost-effective spectrophotometric and chromatographical procedures for quantification of some anti-diabetic drugs in pure and fixed dosage form. newline newlineMaterial and Methods: Various drugs acting as anti-diabetic and their combined pharmaceutical dosage forms i.e. Remogliflozin Etabonate, Vildagliptin Hydrochloride, Metformin Hydrochloride, Teneligliptin Hydrobromide and Pioglitazone Hydrochloride pure drugs were procured from the well-known sources and pharmaceutical dosage forms were purchased from the local medical store. UV- spectroscopic, RP-HPLC and RP-UFLC method to determine assay/content were established and validated as per ICH Q2 (R1) strategies. UFLC methods were also optimized by QbD using Box Behnken Design methodology. Additionally Forced degradation and robustness studies were conducted for HPLC and UFLC methods. newline newline newline newlineResults and Discussion: Determination of Vildagliptin and Remogliflozin was completed by inventing UV spectroscopic and RP-HPLC techniques. Simultaneous determination of Remogliflozin and Metformin was completed by the developed RP-HPLC and RP-UPLC methods, simultaneous estimation of Remogliflozin Etabonate and Teneligliptin Hydrobromide had been carried out by the developing UFLC method; optimization by QbD. Concurrent determination of Metformin hydrochloride, Teneligliptin Hydrobromide and Pioglitazone Hydrochloride had been carried out by the developing UFLC method which was optimization by QbD. Established methods validated as per the ICH Q2 (R1) guidelines. The evaluations of validation were well as per acceptable standards. Forced degradation was executed to certify the probable interference of degradation impurities. Forced degradation studies showed separated peaks of the analytes and degradants. No interference depicted due stress studies for active drugs and degradants. newline newlineConclusion: The anticipated established methodologies were efficaciously validated in accordance to ICH Q2 (R1) and based on outcomes, it was concluded