UV Spectophotometric Method Development & Validation in Bulk Drugs and In Tablet Dosage Form of Sitagliptin by Using Methnol, Water & Acetnitrile as Solvents

This research focused on the development and validation of innovative UV spectrophotometric techniques for the quantification of sitagliptinin pharmaceutical formulations, adhering to ICH Q2 (R1) guidelines. The zero-order derivative spectrophotometric approach proved to be cost-effective and reproducible for both active pharmaceutical ingredients. Key validation parameters, such as accuracy, precision, specificity, and linearity, were rigorously assessed and confirmed compliance with both ICH and USP standards. The methods demonstrated simplicity, reliability, and precision, making them well-suited for routine analytical procedures with high accuracy. The precision of the methods, assessed via repeatability, was validated by analyzing multiple aliquots from homogeneous samples, yielding satisfactory results. When applied to sitagliptin tablet formulations, the methods showed no interference from excipients, highlighting their practical utility in pharmaceutical analysis. Compared to existing techniques, these methods offer significant advantages in terms of sensitivity, simplicity, and cost-efficiency. Moreover, they require only basic instrumentation, which reduces the need for complex procedural steps, additional reagents, or lengthy analysis times. The developed methods' affordability and minimal maintenance requirements make them highly suitable for use in small-scale pharmaceutical industries, ensuring consistent therapeutic efficacy in drug formulations. The primary focus of this study was on optimizing the methods to improve their performance, ensuring that the final methods could be quickly validated and efficiently applied to the analysis of both preclinical and commercial samples. Through a review of the current literature on the analysis of sitagliptin, it was evident that there was a gap in the availability of validated methods for their analysis in bulk and pharmaceutical dosage forms. This study addresses that gap by offering refined UV spectrophotometric methods that meet the required standards for quantitative analysis, demonstrating specificity, linearity, accuracy, and precision. These methods are fully aligned with regulatory requirements, making them ideal for routine use in pharmaceutical quality control.