DEVELOPMENT AND VALIDATION OF SIMPLE STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF ANTI- DIABETIC DRUG TENELIGLIPTIN AND DAPAGLIFLOZIN
Apurwa Sadashiv Shahare, Snehal R. Karmankar
ABSTRACT
This study presents the development and validation of a chromatographic method for the analysis of DAPA (Dapagliflozin) and TNLG (Tolvaptan) in pharmaceutical formulations. The method was thoroughly evaluated for linearity, system suitability, and validation parameters, including recovery studies, repeatability, and precision. Both drugs exhibited excellent linearity with correlation coefficients of 0.999. System suitability results indicated good separation, with acceptable retention times and peak symmetry for both drugs. Validation results confirmed high precision, with mean recovery values near 99% for all concentration levels. The LOD and LOQ values demonstrated that TNLG is more sensitive than DAPA. Additionally, forced degradation studies showed that DAPA exhibited greater stability under oxidative and photolytic conditions compared to TNLG, which was more stable under acidic and alkaline hydrolysis. The results confirm the robustness, accuracy, and reliability of the developed method, making it suitable for routine quality control and stability testing of both drugs in tablet formulations.
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