Abstract

DEVELOPMENT AND VALIDATION OF BATHOCHROMICALLY SHIFTED UV SPECTROPHOTOMETRIC AREA UNDER CURVE METHOD FOR QUANTITATIVE ESTIMATION OF NATEGLINIDE IN API AND TABLET DOSAGE FORM

Manisha S. Phoujdar*, Narendra M. Khairnar and Shwetal P. Vassa

Abstract

The aim of present work was to develop an accurate, precise, reproducible and economical Bathochromically shifted UV spectrophotometric Area under curve method for estimation of Nateglinide. The Area under curve of UV spectrum was calculated between 209.7 to 219.7nm and a simple method was developed. The method has followed linearity in the range of 30-80μg/ml. The value of correlation coefficient was 0.999. This method was validated as per ICH guideline Q2 (R1).[3] Satisfactory values of Percent relative standard deviation for the intra-day and interday precision indicated that method is precise. Results of the recovery studies (99.7% to 101.18%) showed accuracy of the method. LOD and LOQ were calculated as 0.351μg/ml and 1.063μg/ml, respectively. The developed method can be used for routine estimation of Nateglinide in tablet dosage forms.

Keywords: Area under curve, Nateglinide, UV spectrophotometry, Quantitative estimation, Bathochromic shift.