Method Development and Validation for Related Impurities of Sitagliptin by RP-HPLC Method
TL;DR
The validated RP-HPLC method was found to be sensitive, specific, and reliable for routine analysis of Sitagliptin and its related impurities in bulk and pharmaceutical dosage forms and can be effectively employed for quality control and stability studies in pharmaceutical industries.
Abstract
Sitagliptin, an oral antidiabetic agent used in the management of type 2 diabetes mellitus, requires stringent quality control to ensure its safety and efficacy. The present study focuses on the development and validation of a simple, precise, and reliable Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the determination of related impurities in Sitagliptin. Chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase composed of buffer and organic solvent under gradient/isocratic conditions. The detection was carried out using a UV detector at an appropriate wavelength. The method was validated in accordance with International Council for Harmonisation (ICH) guidelines with respect to specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), and robustness. The developed method demonstrated good resolution between Sitagliptin and its related impurities, with acceptable system suitability parameters. Linearity was observed over a suitable concentration range with high correlation coefficients. The recovery studies confirmed the accuracy of the method, while precision studies indicated reproducibility with low %RSD values. The validated RP-HPLC method was found to be sensitive, specific, and reliable for routine analysis of Sitagliptin and its related impurities in bulk and pharmaceutical dosage forms. Hence, the method can be effectively employed for quality control and stability studies in pharmaceutical industries.