Method Development and Validation of Antivira...

Method Development and Validation of Antiviral Combination As Lamivudine, Zidovudine and Nevirapin in Bulk and Pharmaceutical Dosage Form By RP HPLC Method

Author Name : Mr. S. S. Rane, Prof. (Dr.) R. Y. Chaudhari, Prof. (Dr.) V. R. Patil

ABSTRACT

A simple, fast, selective and sensitive high performance liquid chromatographic method has been developed and validated for the simultaneous determination of Lamivudine, Zidovudine and Nevirapin as in bulk drug and in pharmaceutical formulations. The method employed Hibar Purosphere RP- C18 column (250 x 4.6 mm id, 5 μm particle size) as the stationary phase while methanol and phosphate buffer pH adjusted to 3.5 (56: 44 v/v) was used as mobile phase. The method showed good sensitivity with linearity range for Lamivudine, Zidovudine and Nevirapin and with correlation coefficients of 0.998, 0.996 and 0.999 respectively observed at 248 nm wavelength. Best resolution was obtained retention time of 2.397, 2.700 and 7.030 min respectively Lamivudine, Zidovudine and Nevirapin at flow rate of 1.0 ml per minute. Mean percent recovery of triplicate samples at each level for drugs were found in the range of 98.78% to 100.15% with RSD of less than 2.0%. The method was validated according to the guidelines of International Conference on Harmonisation (ICH) and was successfully employed in the estimation of commercial formulations.

Key words: RP-HPLC, Lamivudine, Zidovudine, Nevirapin, Simultaneous estimation, Validation.