ESTIMATION AND VALIDATION OF ENTECAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Abstract

A highly simple, se nsitive, reliable, rapid and specific RP - HPLC method was developed for the determination of Entecavir in tablet dosage form. This m ethod was carried out on a C 18 column (250 x 4.6 mm ID) maintained at 25 0 C . The mob ile phase consisted of a methanol:water (1:1) was pumped at a flow rate of 0.8 ml/m in. The chromatographic separation was obtained with a retention time of 9.36 min utes and the method was in linearity in the range of 5 - 25 µg/ml (r 2 = 0.9991). The accuracy of the method was f ound to be 98.65 - 99.41 %. The limit of detection and limit of quantitation were found to be 0.372 and 1.128 mg/ml, respectively. The method was validated and demonstrated acceptable results for precision and robustness. The system with m ethanol:water (50:50 v/v) with 0.8 ml/min flow rate wa s quite robust. The optimum wavelength for detection was 254 nm at which better detector response for the selected drug was obtained. The average retention time required for the elution of Entecavir was found to be 4.107 + 0.03 min utes . Hence, the developed RP - HPLC method can be adopted for the routine analysis of Entecavir in bulk and pharmaceutical dosage forms in quality control laboratories.