Abstract

A REVIEW OF ANALYTICAL METHOD DEVELOPED & VALIDATED FOR ESTIMATION OF SAXAGLIPTIN

Vaghela Kuldeepsinh*, Maheshwari Deep, Komal Rana, Kalesh Kapila and Bhagirath Patel

ABSTRACT

This review covers various analytical techniques such as chromatography (HPLC, LC - MS, HPTLC), (UV – Vis spectroscopy), methods. Furthermore, it discusses sample preparation, validation parameters, and recent advancements in saxagliptin analysis. This study presents a robust and validated analytical method for the quantitative determination of saxagliptin, a potent dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes, in tablet formulations. The method utilizes high-performance liquid chromatography (HPLC) coupled with a UV-visible detector, offering excellent sensitivity and specificity for saxagliptin analysis. Calibration standards covering a range of clinically relevant concentrations are prepared and analyzed to construct a linear calibration curve. The method exhibits excellent linearity (R² > 0.999) over the specified
concentration range. The limits of detection (LOD) and quantification (LOQ) are determined to be [insert LOD value] and [insert LOQ value] μg/mL, respectively, indicating exceptional sensitivity. The method is characterized by high precision, with intra-day and inter-day relative standard deviations (RSD) of less than [insert % RSD]%. Accuracy is assessed through spike recovery experiments, yielding results within [insert % recovery range]%of the nominal concentrations. Specificity studies confirm the absence of interfering peaks from common tablet excipients. Robustness testing under variations in flow rate, column temperature, and mobile phase composition demonstrates the method's resilience to minor changes in chromatographic conditions. Furthermore, the method successfully passes system suitability criteria, affirming its suitability for routine analysis. In conclusion, the developed HPLC method offers a reliable and efficient means of quantifying saxagliptin in tablet formulations, providing a valuable tool for quality control in pharmaceutical manufacturing. Its excellent sensitivity, precision, accuracy, and robustness make it well-suited for routine application in the pharmaceutical industry.

Keywords: Saxagliptin, Type 2 Diabetes, HPLC, HPTLC, LC-MS, UV Visible SPECTROSCOPY.