ABSTRACT
OBJECTIVE: To develop a method for determination of the contents and related substances in nevirapine zidovudine and lamivudine tablets. METHODS: The samples were separated on a Welch Ultimate AQ-C18 (4.6 mm × 250 mm, 5 μm) column by gradient elution using acetonitrile-methanol-0.025 mol·L-1 ammonium acetate solution (pH 4.0) as the mobile phase at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 277 nm, and the column temperature was 30°C. RESULTS: Nevirapine, lamivudine, and zidovudine had good liner relationship in the range of 10.3 - 310.9, 7.9 - 237.1, and 14.9 - 449.6 μg·mL-1, respectively. The correlation coefficients were all more than 0.9998. The average recoveries were 100.6% (RSD 0.4%), 100.0%(RSD 0.7%), and 100.2% (RSD 0.6%), respectively. Complete separation was achieved for the related substances (lamivudine acid, lamivudine related compound B, uracil, cytosine, thymine, nevirapine related compound A, and nevirapine related compound B). Cytosine, uracil, and thymine had good liner relationship in the range of 76.8 - 1152, 76.8 - 1152, and 744-14880 ng·mL-1, respectively. The correlation coefficients were all more than 0.9991. The average recoveries were 101.5% (RSD 4.8%), 102.8% (RSD 4.2%), and 101.2% (RSD 1.2%), respectively. CONCLUSION: The method is rapid, simple, and accurate with good reproducibility. It can be used for the quality control of nevirapine zidovudine and lamivudine tablets.