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REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) METHOD DEVELOPMENT AND VALIDATION OF SAXAGLIPTIN FROM HUMAN URINE

Amol S. Bansodea *, Shubhangee S. Gaikwada and Vishal D. Shelkeb

a Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Savitribai Phule Pune University, Narhe, Pune - 411 041, Maharashtra, India

b Department of Quality Assurance Techniques, Sinhgad Institute of Pharmacy, Savitribai Phule Pune University, Narhe, Pune - 411 041, Maharashtra, India

For Correspondence: E-mail: amol.bansode12@gmail.com

 

https://doi.org/10.53879/id.59.12.12828


ABSTRACT

Reversed phase high performance liquid chromatography (RP-HPLC) method for the quantitative determination of saxagliptin (SXG) in human urine was developed and validated to support clinical studies. Chromatographic separation was achieved on an Inertsil® column (250 mm x 4.6 mm, 5 µm). Isocratic elution using a mobile phase of potassium dihydrogen phosphate buffer pH (3) - acetonitrile (80:20, V/V) at a flow rate of 1 mL min-1 with UV detection at 212.1 nm was performed. The retention time of saxagliptin was 6.4 min. The method was validated according to United State Food and Drug Administration (USFDA) (May-2001) guidelines. The developed bioanalytical method was found to be selective, accurate, precise, and having good extraction efficiency. The developed method was satisfactorily applied to the routine quality control analysis of the saxagliptin.

Year 2022 | Volume No. 59 | Issue No.12 | Page No. 50-54
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