Developing a Validated RP-HPLC Chromatographic Method for the Identification of Rosuvastatin and Teneligliptin and its related Impurities in Pharmaceutical Tablet Dosage Form

Abstract

Introduction: Diabetes and cholesterol are major global health issues, affecting millions worldwide. Diabetes, including type 1 (insufficient insulin) and type 2 (insulin resistance), is rising rapidly, contributing to severe complications and deaths. High cholesterol, often linked to lifestyle factors, increases the risk of cardiovascular diseases, necessitating effective management and prevention strategies.

Objectives: Reverse phase gradient high-performance liquid chromatography (RP-HPLC) is a simple, cost-effective, linear, accurate, and selective approach that has been developed and validated to assess the related impurities of Rosuvastatin and Teneligliptin in a combination of tablet dose form.

Methods: Analysis was conducted on a 250 mm x 4.6 mm, 5 µm Hypersil BDS C18 column using Acetonitrile (ACN) in Channel A and 1 % formic acid pH 4 in Channel B with 70:30v/v ratio at a detection wavelength of 280 nm and a flow rate of 1 ml/min. The analyticalmethod was validated according to ICH (International Council for Harmonisation) guidelines.

Results: The linearity of Rosuvastatin (25-75 µg/ml) with LOQ 0.51 µg/ml, Teneligliptin (12.5-37.5 µg/ml) with LOQ 0.258 and Teneligliptin Impurity (2.5-7.5 µg/ml) with LOQ 0.086 µg/ml. The correlation coefficient was consistently observed to be not less than 0.99 for all analytes. The % Recovery value was found to be 100.01% minimum and 100.38% maximum for Rosuvastatin, 100.25% minimum and 103.56% maximum for Teneligliptin and 98.25 % minimum and 101.16 % maximum for impurity A. Limit of Detection was found to be 0.17 µg/ml for Rosuvastatin, 0.085 µg/ml for Teneligliptin and 0.0286 µg/ml for Teneligliptin impurity A. The relative standard deviation value for repeatability, Interday precision and Intraday precision was less than 2%.

Conclusion: This RP-HPLC technique is reliable, efficient, and well-suited for accurately quantifying Rosuvastatin and Teneligliptin, including the detection of Teneligliptin Impurity A, in combined tablet formulations.