A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF NATIGLINIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Challa Sudheer*, B. Tirumaleswara Rao, S. Madhavi and C. Rambabu*

ABSTRACT

A new simple, accurate, stability indicating RP-HPLC method has been developed and validated for assay of Nateglinide in pure and dosage forms. Chromatographic analysis of Nateglinide in the present assay was carried out isocratically with a mobile phase consisting of 0.02M ammonium dihydrogen phosphate buffer (pH-4.0) and acetonitrile in the ratio of 40:60v/v. The flow rate was 1.0ml/min. The effluent was monitored spectrophotometrically at a wavelength of 226nm at ambient temperature with a retention time of 4.189 min respectively. The proposed RP-HPLC method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. The drug substance (Nateglinide) was subjected to stress conditions of hydrolysis, photolysis degradation. The degradation of Nateglinide was observed under acid, base and photolyticstress conditions and was found to be stable in other stress conditions studied.the oxidative stress studies revealed that natiglinide(Rt=4.189 min) was not fully degraded and its degradation products were eluted separatly at different retention times respectively. The percentage RSD for precision and accuracy of the proposed method for Nateglinide was found to be less than 2%. The proposed RP-HPLC method was successfully applied for routine analysis of Nateglinide in tablet dosage form.

Keywords: Nateglinide, RP-HPLC, Validation.