Abstract

R. S. Ch. Phani.*, K. R. S. Prasad and Useni Reddy Mallu

DOI : http://dx.doi.org/10.13005/ojc/320246

Objective of the present research work isto develop a sensitive, selective and accurate new RPHPLC method with UV detection and determination for estimation of Nevirapine (NVP)and its impurities in bulk drug.The separation and quantification was achieved with KromosilC 18 isocratic column, (150 mm × 4.6 mm i.d., particle size 3.5μm, maintained at ambient temperature), HPLC system (Peak LC P7000), a mixture of 20%acetonitrile, 80% buffer (sodium per chlorate) (v/v), at pH of 4.8 and the flow rate was set at 1.0 ml/min. and UV detection at 220 nm. The retention time for NVP, Impurity-A and Impurity-B were found to be 5.5, 7.8, 3.4 min respectively. The method was validated for Linearity, Accuracy, and Precision. The Limit of detection of NVP, Impurity-A and Impurity-B  were found to be 0.03, 0.03, 0.03(µg/ml) respectively.

Nevirapine; ICH guidelines; RP-HPLC; RS Method; Validation

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