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。
Objetive:To detemine the content of nevirapine in tablets.Methods:The first order derivative spectrometry for the determination of nevirapine was developed using amplitudes at 275 nm(peak) and 299 nm(valley)with comparable accuracy and precision to the RP-HPLC method and zero order derivative spectrometry,the quantification was carried out on a Shimadzu ODS column(250 mm × 4.6 mm,5 μm),with mobile phase consisting of methanol and acetate buffer in the ratio of(60∶ 40)(pH = 3).The mobile phase was pumped at a rate of 1 mL.min-1,at 35 ℃ with the detection at 282 nm.Results:The concentration of nevirapine within 2.5-25.0 μg.mL-1recovery was 99.5%(RSD = 1.5%).Statistical test results showed that there is no significant difference between this method and RP-HPLC method,but the zero order derivative UV spectrometry method had significant difference with RP-HPLC method.Conclusions:This method was found to have suppressed the background absorption from the excipients with 12.5 μg.mL-1 presented a good linear relation(r = 0.9997) with the amplitudes and the average comparable accuracy and precision,and found to be simple,quick and accurate.It is suitable forquality control of this preparation.