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目的:建立测定奈韦拉平片中奈韦拉平含量的方法。方法:采用一阶导数UV光谱法,以275 nm(峰)与299 nm(谷)振幅值为定量依据,进行定量分析。该法与RP-HPLC法和零阶导数光谱法进行了对比。色谱柱为Shimadzu ODS(250 mm×4.6 mm,5μm),流动相为甲醇-水(用磷酸调pH=3),(60∶40),流速为1.0 mL.min-1;紫外检测波长282 nm,柱温35℃,采用外标法计算含量。结果:结果表明奈韦拉平浓度在2.5～25.0μg.mL-1范围内与振幅值呈良好的线性关系(r=0.9997),平均回收率为99.5%(RSD=1.5%)。统计检验发现HPLC法与一阶导数UV法无显著性差异,而与零阶导数法有显著性差异。结论:一阶导数UV光谱法可靠,简便快速,可有效消除赋形剂干扰,结果准确,可用于奈韦拉平片的质量控制。
Objective: To establish a method for the determination of nevirapine in nevirapine tablets. Methods: The first derivative UV spectroscopy was used to quantitatively analyze the amplitudes of 275 nm (peak) and 299 nm (valley). This method is compared with RP-HPLC and zero-order derivative spectroscopy. The column was Shimadzu ODS (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-water (adjusted to pH = 3 with phosphoric acid) (60:40) at a flow rate of 1.0 mL · min- , Column temperature 35 ℃, using external standard method to calculate the content. Results: The results showed that the concentration of nevirapine in the range of 2.5 ~ 25.0μg.mL-1 showed a good linear relationship with the amplitude (r = 0.9997). The average recovery was 99.5% (RSD = 1.5%). Statistical test found no significant difference between the HPLC method and the first derivative UV method, and the zero derivative method was significantly different. Conclusion: The first derivative UV spectrophotometry is reliable, simple and rapid, can effectively eliminate the interference of excipients and has accurate results. It can be used for the quality control of nevirapine tablets.