复方烟酰胺替硝唑凝胶含量测定方法的比较研究

Comparative studies on determination of compound nicotinamide and tinidazole Gel

目的 建立适用于医院制剂质量控制的快速测定法。方法 HPLC法 :DiamonsilC18柱 (2 5 0mm× 4 6mm ,5 μm) ,甲醇 水 (45∶5 5 )为流动相 ,检测波长 2 78nm ,流速 1 0 0ml·min-1,进样量 2 0 μl。差示分光光度法 :根据吸收光谱特征 ,选择替硝唑在2 80～ 2 4 5nm等吸收消去测定烟酰胺含量。结果 烟酰胺、替硝唑两组分回收率为HPLC法 :10 0 5 9%和 10 0 2 4 % ,RSD为1 0 2 %和 0 72 % (n =5 ) ;差示分光光度法 :10 0 5 3%和 99 94 % ,RSD为 0 33%和 0 2 1% (n =5 )。结论 差示分光光度法是快速。

AIM To estabilish rapid method for assay of compound nicotinamide and tinidazole Gel. METHODS\ HPLC method:Diamonisl C 18 column (250 mm×4 6 mm,5 μm), the mobile phase:methanol water(45∶55), the wavelength of UV detector:278 nm. Dual wavelength differential spectrometry:equal absorbing 280～245 nm wavelength of tinidazole were selected to eliminate interference. RESULTS\ The recovery of nicoamide and tinidazole by HPLC method:100 59% and 100 24%, RSD was 1 02% and 0 72% respectively( n=5 );by dual wavelength differential spectrometry method:100 53% and 99 94%, RSD were 0 33% and 0 21% respectively( n=5 ). CONCLUSIONS The dual wavelength differential spectrometry is suitable for quantitation analysis on the preparation. It is simple and accurate.