Development And Validation Of Uv Spectrophotometric Method For The Determination Of Sitagliptin In Bulk Material And In Tablets

Abstract

This study developed and validated novel UV spectrophotometric methods according to ICH Q2 (R1) guidelines for the quantitative analysis of tolvaptan and carvedilol in pharmaceutical dosage forms. The zero-order derivative method was found to be economical and reproducible for both drugs. Validation parameters such as accuracy, precision, specificity, and linearity were thoroughly evaluated, demonstrating compliance with ICH and USP requirements. The methods exhibited simplicity, accuracy, and precision, making them suitable for routine laboratory analysis with high levels of accuracy and precision.

The precision of the methods, measured in terms of repeatability, was determined by analysing a sufficient number of aliquots from homogeneous samples, showing satisfactory results. Application of the developed methods for analysing tolvaptan tablet dosage forms revealed no interference from excipients, highlighting their applicability in pharmaceutical analysis. These methods offer advantages over existing ones regarding sensitivity, simplicity, cost-effectiveness, and experimental conditions.

Furthermore, the developed UV-spectrophotometric methods do not entail tedious procedural steps, additional reagents, or prolonged analysis times, requiring only simple instrumentation. Their cost-effectiveness and minimal maintenance make them suitable for application in smallscale industries, ensuring therapeutic efficacy in pharmaceutical formulations.

Efforts were primarily directed towards method development and optimization to enhance final method performance. A well-developed method should be easy to validate and capable of rapidly analyzing preclinical samples, formulations, and commercial samples. Reviewing existing literature on tolvaptan and carvedilol analysis indicated a gap in methods for determination and validation in bulk and pharmaceutical dosage forms. Thus, this study addresses this gap by presenting improved UV spectrophotometric methods for the quantitative analysis of tolvaptan and carvedilol in pharmaceutical formulations. The developed methods demonstrate specificity, linearity, accuracy, precision, and compliance with regulatory requirements, making them suitable for routine analysis in pharmaceutical quality control.