高效液相色谱法测定乳酸依沙吖啶凝胶中乳酸依沙吖啶的含量
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摘要
目的应用高效液相色谱法测定乳酸依沙吖啶凝胶中乳酸依沙吖啶的含量。方法色谱柱为Agilent TC-C_(18)(2)(4.6mm×150mm,5μm),以含0.1%辛烷磺酸钠的溶液[磷酸盐缓冲液(取磷酸二氢钠7.8g,加水900mL溶解后,用磷酸调节pH值至2.8,用水稀释至1000mL,即得)]-乙腈(700∶300)为流动相,流速1.0mL·min~(-1),柱温30℃,检测波长270nm,进样量:20μL。结果乳酸依沙吖啶在49.05～588.60ng范围内线性关系良好(r=0.9998),平均回收率为99.4%(RSD=1.9%,n=5)。结论该方法准确、简便、快速,可用于乳酸依沙吖啶凝胶的质量控制。
OBJECTIVE To establish an HPLC method for the assay of ethacridine lactate in ethacridine lactate gel. METHODS In this system of HPLC,an Agilent TC-C18( 2) column( 4. 6 mm × 150 mm,5μm) was used as analytical column. Using 0. 1% Sodium octanesulfonate solution[Phosphate buffer( add 7. 8 g sodium dihydrogen phosphate into 900 mL water,adjusted to pH 2. 5 with phosphoric acid,then add water to 1000 mL ]-acetonitrile( 700∶300) as the mobile phase,the flow rate was 1. 0 mL·min-1 and the column temperature was maintained at30℃ with the detective wavelength was set at 270 nm,The inject volume was 20μL. RESULTS The linear range was 49. 05 ～ 588. 60 ng,r = 0. 9998. The average recovery was 99. 8%,and RSD = 2. 0%( n = 5). CONCLUSION The method is convenient,rapid,accurate,and suitable for the determination of ethacridine lactate gel.
OBJECTIVE To establish an HPLC method for the assay of ethacridine lactate in ethacridine lactate gel. METHODS In this system of HPLC,an Agilent TC-C18( 2) column( 4. 6 mm × 150 mm,5μm) was used as analytical column. Using 0. 1% Sodium octanesulfonate solution[Phosphate buffer( add 7. 8 g sodium dihydrogen phosphate into 900 mL water,adjusted to pH 2. 5 with phosphoric acid,then add water to 1000 mL ]-acetonitrile( 700∶300) as the mobile phase,the flow rate was 1. 0 mL·min-1 and the column temperature was maintained at30℃ with the detective wavelength was set at 270 nm,The inject volume was 20μL. RESULTS The linear range was 49. 05 ～ 588. 60 ng,r = 0. 9998. The average recovery was 99. 8%,and RSD = 2. 0%( n = 5). CONCLUSION The method is convenient,rapid,accurate,and suitable for the determination of ethacridine lactate gel.
引文
[1]卫生部药品标准[S].中药成方制剂,第七册,1998,152.
[2]国家药典委员会编.中国药典[S].二部.北京:化学工业出版社,2015,679.
[2]国家药典委员会编.中国药典[S].二部.北京:化学工业出版社,2015,679.