Volume : 12, Issue : 10, October – 2025

Title:

RP-HPLC METHOD AND ITS VALIDATION FOR ANALYSIS OF SAXAGLIPTIN AND METFORMIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Authors :

A. Akhila* , Dr. Gadipally. Sai kiran, Dr. D. Venkata Ramana.

Abstract :

A rapid, precise, and validated Reverse Phase High-Performance Liquid Chromatographic (RP-HPLC) method was developed for the simultaneous estimation of Saxagliptin and Metformin in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a Symmetry ODS C18 column (4.6 mm × 150 mm, 5 µm particle size) maintained at a temperature of 38°C. The mobile phase consisted of Methanol and 0.1% Orthophosphoric acid (64:36 v/v), delivered at a flow rate of 1.0 ml/min. Detection was carried out at a wavelength of 224 nm using a Waters Alliance 2695 HPLC system equipped with a PDA Detector (996 model). The injection volume was 20 µl, and the total run time was 7 minutes. The method was validated according to ICH Q2(R1) guidelines and demonstrated excellent linearity, accuracy, precision, specificity, robustness, and acceptable limits of detection and quantification for both drugs. The results confirm that the method is suitable for the simultaneous determination of Saxagliptin and Metformin in both active pharmaceutical ingredients (API) and finished dosage forms. This validated method can be reliably employed in routine quality control and stability testing within pharmaceutical laboratories.
Keywords: RP-HPLC, Saxagliptin, Metformin, Symmetry ODS C18 column, simultaneous estimation, validation.

Cite This Article:

Please cite this article in press A. Akhila et al., Rp-Hplc Method And Its Validation For Analysis Of Saxagliptin And Metformin In Bulk And Pharmaceutical Dosage Form , Indo Am. J. P. Sci, 2025; 12(10).

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