Development and Validation of Stress Induced Stability Indicating UV-Spectroscopic Method for Nateglinide Bulk and Pharmaceutical Formulations

The present study describes a simple, accurate, precise and cost effective UV-VIS Spectrophotometric method for the estimation of Nateglinide, an anti-diabetic drug, in bulk and pharmaceutical dosage form. The solvent used was 0.1 N HCl+ 0.5 SLS solution and the λ max or the absorption maxima of the drug was found to be 212 nm. A linear response was observed in the range of 10- 60μg/ml with a regression coefficient of 0.999. The method was then validated for different parameters such as Linearity, Accuracy, Precision, Specificity, Robustness, Ruggedness, Limit of Detection and Limit of Quantification (LOQ). This method can be used for the determination of Nateglinide in quality control of formulation without interference of the excipients. Nateglinide was subjected to stress degradation under different conditions recommended by ICH such as acid, alkali, photolytic, dry heat and oxidative. The samples so generated were used for degradation studies using the developed method.