World Journal of
Pharmaceutical and Life Sciences

A COMPREHENSIVE REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF ANTI-DIABETIC DRUGS BY HPLC

K. Pravalika*, M. Srikanth Reddy, B. Gayatri, Arunabha Mallik

ABSTRACT

High-performance liquid chromatography (HPLC) remains the cornerstone analytical technique for the assay, impurity profiling, stability testing and bioanalysis of anti-diabetic drugs. The expanding therapeutic classes biguanides, sulfonylureas, meglitinides, thiazolidinediones, DPP-4 inhibitors, SGLT2 inhibitors and GLP-1 analogues bring diverse chemical properties that challenge chromatographic separation and detection. This review summarizes method-development strategies and validation requirements for anti-diabetic pharmaceuticals using HPLC. Key topics include analyte physicochemistry and its implications for mobile phase and column selection, sample preparation approaches (including extraction and derivatization), choice of detection (UV, PDA, fluorescence, MS), gradient vs. isocratic strategies, forced-degradation/stability-indicating method development, and implementation of Analytical Quality by Design (AQbD) and green analytical principles. We discuss method validation according to regulatory guidelines (specificity, linearity, accuracy, precision, LOD/LOQ, robustness, system suitability and stability) and practical troubleshooting tips. Representative chromatographic conditions for common anti-diabetic drugs are summarized to aid rapid method transfer. Finally, we identify gaps particularly for new SGLT2 and GLP-1 analogues where more stability-indicating and LC-MS/MS methods are needed and propose future directions such as increased use of UHPLC, hyphenated MS detection for specificity, and adoption of AQbD for robust, scalable methods.

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