Method Development and Validation of RP-HPLC Method for Estimation of Nateglinide in Bulk Drug and Pharmaceutical Formulation.

A rapid, simple, precise and sensitive RP-HPLC method was developed for estimation of nateglinide in pharmaceutical bulk drug and pharmaceutical formulation. A phenomenex Gemini C18, 5μm particle size column having 250 x 4.6 mm.i.d in isocratic mode, with mobile phase containing acetonitrile: 0.1%w/v sodium dihydrogen ortho phosphate (70:30v/v) was used. The flow rate was 2ml/min and the effluent was monitored at 220nm. The retention time of nateglinide was 6.7±0.2 minutes. The method was validated for linearity, accuracy, precision, specificity, LOD, LOQ and robustness. Nateglinide showed linear response in the concentration range 160–240μg/ml. the correlation coefficient for nateglinide was 0.9999 and the percentage recovery was found to be 99.26 to 100.81.