Bioanalytical method development and validation for simultaneous estimation of Teneligliptin and Rosuvastatin in plasma by RP-HPLC
Abstract
A simple, precise, and robust reverse phase high-performance liquid chromatography (RP HPLC) method was developed and validated for the simultaneous estimation of Teneligliptin (TGL) and Rosuvastatin (RVS) in plasma. Chromatographic separation was achieved using a C18 column (4.6 × 250 mm, 5 μm) with a mobile phase of water–acetonitrile (50:50, pH 2.8 adjusted with formic acid) at a flow rate of 1.2 mL/min. Detection was performed at 265 nm with a run time of 10 minutes. The retention times of TGL and RVS were 2.464 min and 7.733 min, respectively. The method was validated according to ICH Q2(R1) guidelines for system suitability, specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). Linearity was observed in the range of 6–16 µg/mL for both drugs, with correlation coefficients of 0.9956 (TGL) and 0.9913 (RVS). Recovery studies demonstrated mean recoveries of 98.31% for TGL and 98.86% for RVS, confirming accuracy. Precision studies showed %RSD values below 0.2%, indicating excellent reproducibility. The LOD and LOQ were 0.92 µg/mL and 2.79 µg/mL for TGL, and 1.29 µg/mL and 3.91 µg/mL for RVS, respectively. The method proved to be specific, accurate, and reliable for bioanalytical applications, making it suitable for pharmacokinetic and clinical research studies.
How to Cite
Abhilasha Kumari, Sushila Kaura, "Bioanalytical method development and validation for simultaneous estimation of Teneligliptin and Rosuvastatin in plasma by RP-HPLC", Vol. 4, Issue 6, 28-09-2026, pp. 44-60. DOI: 10.5281/zenodo.23388661
