METHOD DEVELOPMENT AND VALIDATION OF SAXAGLIPTIN BY USING UV SPECTROPHOTOMETRIC AND RP-HPLC TECHNIQUES IN BULK AND TABLET DOSAGE FORM

ABSTRACT

Simple, precise, economical, fast and reliable UV and RP- HPLC Techniques have been developed for the estimation of Saxagliptin in bulk and pharmaceutical dosage form. UV method is based on measurement of absorption at maximum wavelength of 281 nm for Saxagliptin. Linearity for detector response was observed in the concentration range of 1 - 18μg/ml. The accuracy of the methods was assessed by recovery studies and was found to be 98.26 to 101.143 %. Separation was achieved with an Inertsil ‐ Extend ‐ C18 (250 × 4.6 mm, 5 µm) HPLC column. A mobile phase comprising Methanol and Water (40:60) was developed. The detection was carried out by using a UV detector set at a wavelength of 281nm. Validation experiments were performed to demonstrate linear over the concentration range of 10 ‐ 125μg/ml and get the correlation Regression (r2) 0.999, showed good recoveries (98.95 – 101.22 %), the % relative standard deviations of Injection Precision and Method Precision were 0.044 and 0.0807 % respectively. The method can be used for quality control assay of Saxagliptin.

KEYWORDS: UV-Spectrophotometry, RP-HPLC, Saxagliptin, Validation, and ICH guidelines.