A Simple RP-HPLC Method to Simultaneously Assay the Contents of Lamivudine, Tenofovir, and Nevirapine in Fixed Dose Combined Oral Antiviral Medicines

Abstract EN

An accurate and rapid reverse HPLC method has been developed and validated for the simultaneous quantification of lamivudine, nevirapine, and tenofovir disoproxil fumarate.

Suitable separation was achieved on Phenomenex Synergi C18 (250 × 4.6 mm, 4 μm) using mobile phase, methanol (50%): ammonium acetate buffer (adjusted to pH 2.80) (40%): acetonitrile (10%) in an isocratic mode.

The drugs were detected at 270 nm with a flow rate of 1.0 ml/min, and the retention times were found to be 3.26, 5.42, and 7.55 minutes for lamivudine, nevirapine, and tenofovir disoproxil fumarate, respectively.

The developed method was validated per ICH guidelines.

Good linearity was obtained within the concentration ranges of 10–59 µg/ml, 7–42 µg/ml, and 15–90 µg/ml with a correlation coefficient of not less than 0.990.

The % RSD values for precision (intraday and interday) and accuracy studies were found to be less than 2%.

The results obtained from quantitative analysis conform to USP content requirements for marketed tablet dosage forms, RICOVIR-LN, and tenofovir disoproxil fumarate/lamivudine tablets.

The method is therefore useful for routine quality control of antiretroviral tablet dosage forms containing tenofovir disoproxil fumarate, lamivudine, and nevirapine.