O-PHTHALALDEHYDE BASED SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF SITAGLIPTIN IN TABLETS

摘要

Objective: The objective of the method was to develop a simple, cost effective and reproducible spectroscopic method for the determination of sitagliptin (STG) in bulk and tablets. Methods: In this method, sitagliptin reacted with o-phthalaldehyde (OPA) and n-acetyl cysteine (NAC) in a borate buffer (pH 9.8)at room temperature to produce a chromogen. The absorption of reaction product was measured at 338 nm. Results: The method was linear in a concentration range between 5 and 120μg/ml. The regression line equation was: Y = 0.0140X + 0.0503 with a regression coefficient of 0.9997 (n=6). The limit of detection (LOD) and limit of quantitation (LOQ) were 1.1 and 3.7μg/ml, respectively. The precision was satisfactory; the values of relative standard deviation (RSD) had not exceeded 2%.The average values of recovery study were found to be in the range98.82 - 100.2 ± 0.28 – 1.12%. Conclusion: The developed method was simple, fast, accurate and precise. It could be applied for routine quality control analysis of STG in tablets.