双波长等吸收紫外法同时测定复方阴道泡腾片中酮康唑与替硝唑含量

Simultaneous determination of ketoconazole and tinidazole using two-wavelength equal-absorbance UV method

目的建立同时测定酮康唑和替硝唑含量的双波长等吸收紫外分光光度法。方法建立双波长法测定酮康唑和替硝唑含量的标准曲线,并考察检测方法的精密度和回收率。结果选择317nm作为替硝唑的测定波长,221nm作为酮康唑的含量测定波长,并以352nm作为参比波长。二者标准曲线方程为:A=0.029C+0.0168;A=0.456C-0.0742,高、中、低浓度的平均回收率分别为(100.2±0.70)%;(99.4±0.92)%,测定的日内精密度RSD分别为0.62%,1.03%;日间精密度RSD为1.13%,1.42%。结论双波长等吸收紫外光度法同时测定酮康唑和替硝唑含量的方法学特异性好,精密度和回收率符合测定要求,测定结果可靠。

Objective To establish the two-wavelength ultraviolet spectrophotometry （TWUS） on the assay of ketoconazole and tinidazole. Methods Standard curves were established to assay ketoconazole and tinidazole, and the verified items included precision and rate of recovery were also investigated. Results Wavelength of 317nm was chosen to detect the content of tinidazole and wavelength of 221nm and 352nm was chosen as a pair of equal point of absorbance, which was used to detect the content of ketoconazole. The standard equations of the line were A=0.029C＋0.0168; A=0.456C-0.0742. The average relative rates of recovery in three levels were （100.2 ±0.70） % and （99.4 ± 0.92） %. During one day, the RSD of precision were 1.13% and 1.42%, and within days, the RSD of precision were 1.13% and 1.42%. Conclusions All the data of each verified item are in accordance with the national relevant rules, which indicate that two wavelength ultraviolet spectrophotometry is a reliable method for simultaneous determination of ketoconazole and tinidazole.