高效液相色谱法及紫外分光光度法测定替加色罗片的含量

目的 :建立替加色罗片剂含量测定的HPLC法和UV法。方法 :HPLC法———采用C18柱 ,流动相为乙腈∶1%十二烷基硫酸钠缓冲溶液 (含0 .95 %冰醋酸 ) =5 6∶4 4。流速 :2mL·min- 1。检测波长 :314nm。柱温 :4 0℃。UV法———在 314nm处测定替加色罗的吸收度。结果 :HPLC法在 0 .1～ 12 0mg·L- 1的范围内 ,将峰面积A与浓度C进行回归处理 ,A =2 8.93C - 14 .4 6 (r =0 .9999,n =6 ) ,日内RSD≤ 1.11% ,日间RSD≤ 3.0 9% ,回收率在 10 0 .4 2 %～ 10 3.82 %之间。UV法在 2～ 2 0mg·L- 1范围内线性良好 ,回归方程为A =5 4.2 8C +0 .0 14 8(r =0 .9998,n =7) ,日内RSD≤ 0 .70 % ,日间RSD≤ 0 .92 % ,回收率在 10 1.0 6 %～ 10 3.0 2 %之间。 2种方法测得 3批样品的标示量百分含量均在规定范围内 (90 %～ 110 % )。结论 :HPLC法和UV法均适用于替加色罗片剂的含量测定 ,由于UV法更简便易行 ,在对有关物质进行了较好控制的情况下 ,此法更为适用

HPLC and UV methods for determination of content of tegaserod tablet

AIM: To establish UV and HPLC methods to determine the content of tegaserod tablet. METHODS: HPLC method——the separations were obtained on a Diamonsil C18 column which was maintained at 40 ℃, the mobile phase was acetonitrile 1% sodium dodecyl sulfate (contain 0.95% acetic acid) (56∶44, V∶V), the flow rate was 2 mL·min -1 and the detection wavelength was 314 nm. UV method——absorption was determined at 314 nm. RESULTS: HPLC method——calibration was linear from 0.1-120 mg·L -1 ( r =0.9999). Within day and between day coefficients of variation were less than 3.1 % . The recovery was between 100.42 % - 103.82 % . UV method——calibration was linear from 2-20mg·L -1 ( r =0.9998). Within day and between day coefficients of variation were less than 1%. The recovery was between 101.06 %-103.02 %. CONCLUSION: HPLC and UV method both appear to be suitable for determination of the content of tegaserod tablet while we are apt to use the UV method for its simplicity if the related impurity is controlled well.