VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF SITAGLIPTIN IN BULK AND TABLET DOSAGE FORM

Anusha M. S.*, Sowmya H. G. and Jose Gnana Babu C.

ABSTRACT

Simple, precise and accurate area under curve spectroscopic method has been developed and validated for the estimation of Sitagliptin in bulk and Pharmaceutical dosage form. The drug shows maximum absorption (λ max) at 267nm in 0.1N Sulphuric acid solution and Area under Curve [AUC] in absorption spectra was measured between the wavelength range 262 to 272nm which obeys Beer’s law in the concentration range of 10-50μg/ml. The linearity study was carried out and regression coefficient was found to be 0.9999 and it has showed good linearity, precision during this concentration range. The % recovery was found to be 98.85-99.1. The LOD and LOQ was found to be 0.4472 and 1.35μg/ml. The % relative standard deviation was found to be less than 2. As per ICH guidelines the method has been validated for linearity, precision, accuracy, robustness, ruggedness, LOD and LOQ. The developed and validated method can be successfully applied for reliable quantification of Sitagliptin in bulk and pharmaceutical dosage form.

Keywords: Sitagliptin, Area under curve spectroscopy, Validation, Pharmaceutical formulations.