Abstract

UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF SITAGLIPTIN IN API AND IN PHARMACEUTICAL DOSAGE FORM

R. N. Jalkote* and Prof. Dr. M. S. Kalshetti

ABSTRACT

A simple, precise, accurate, economical and reliable UV Spectrophotometric method has been developed for the estimation of Sitagliptin in tablet dosage form. The drug shows maximum absorption at 266 nm in water and methanol (70:30) and obeys Beer’s law in the concentration range of 20-100 μg /mL with good correlation coefficient (R2=0.9993). The results of analysis were validated by recovery studies. The recovery was found to 96.375-100.171%. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.82 μg/ml and 8.57μg/ml respectively. The relative standard deviation was found to be < 2.0 % in all cases. The Proposed Spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The proposed method can be used for the reliable quantification of Sitagliptin in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Sitagliptin, UV Spectrophotometry, Absorbance maxima, Method validation.