Quality by Design Approach for Development and Validation of Uplc and Hplc Methods to Quantify the Pharmaceutically Important Molecules

Abstract

The quality of medicines plays a major role for treating the patients for different ailments to protect the health. The finished drug products with quality, safety, and effectiveness will be ensured by analytical testing using scientifically developed methods in the pharma industry. A systematically driven approach of quality-by-design was used during development of UPLC and HPLC methods for chromatographic resolution of peaks to quantify the pharmaceutically important molecules. The design- of-experiments were performed, where a methodology (response-surface), design (central-composite) and model (quadratic) were selected. The results obtained during experimentation was evaluated and established the design-space. The conditions from centre-point of the design-space were chosen as robust chromatographic parameters. newline newlineQbD approach based UPLC analytical procedure was developed for estimation of medicinally important drug molecule Teriflunomide in existence of impurities with one minute run-time. A UPLC methodology was established for estimation of combination drugs i.e., Ivabradine and Carvedilol in a single run in existence of impurities with 2 minute run-time. A gradient-elution methodology by UPLC was developed for quantification of Ivacaftor related substances in the tablets with a gradient of 5 minutes. An isocratic UPLC method was optimised for assay of anti-schizophrenic drug brexpiprazole in presence of impurities with a 2 minute run-time. LC-MS compatible HPLC by RI-detection method was developed for sodium dodecyl-sulfate estimation and used for identification of other alkyl sulfate in the Sodium dodecyl- sulfate.The related substances method by UPLC was developed for Varenicline citrate with 6 minute run-time. The method validation of present methods is carried out considering the guidelines stated in the ICH Q2 (R1) (1996) .