盐酸赛庚啶片溶出度检查方法的改进  

Dissolution determination of Cyproheptadine hydrochloride tablets

作　　者：尹娜娜[1,2] 苗爱东[2] 徐轶飞[2] 石立娜[1,2] 

机构地区：[1]河北北方学院,河北张家口075000 [2]北京军区联勤部药品仪器检验所,北京100071

出　　处：《华西药学杂志》2014年第2期173-175,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的改进盐酸赛庚啶片溶出度的检查方法。方法以900mL0．1mol·L-1盐酸溶液为溶出介质，转变为50r·min-1，30min时取样；采用ZorbaxSB—C18色谱柱（150mm×4．6mm，0．5μm），流动相为甲醇一0．1％磷酸溶液（每100mL中加0．1g十二烷基磺酸钠）（75：25），流速1．0mL·min-1，柱温30℃，检测波长230nm。结果0．224～8．96μg·mL-1盐酸赛庚啶与峰面积呈良好的线性关系，回归方程为Y=265．27X-23．806（r=0．9991，n=6），平均回收率为101．68％（RSD=2．3％，n=9）。按《美国药典》中的限度为标示量的80％作为标准，6个厂家14批次样品的不合格率为42．86％。结论改进后的方法简便易行、准确度高、重复性好，可用于该制剂的质量控制。OBJECTIVE To establish a conventional method for the dissolution determination of Cyproheptadine hydrochloride tablets. METHODS The dissolution rate was determined by HPLC with 900 mL of 0. 1 tool- L- 1hydrochloric acid as dissolution medium and rotation speed was at 50 r.min-1. Not less than 80% of the labeled amount of C21H21N· HC1 was dissolved in 30 min. The Agilent Zorbax SB -C18 column（150mm×4.6mm,0.5μm）was used with methanol -0.1% phosphoric acid（ every 100 mL contai- ning 0.1 g sodium dodeeyl sulfonate） （75 ： 25 ） as mobile phase at 30 ℃. The detecting wavelength was 230 nm. The flow rate was 1.0 mL- rain -1. RESULTS The caliblation curve was linear within the range of 0. 224 - 8.96 μg- mL - 1 （ r = 0.9999, n = 6 ）. The average recovery was 101.68% with the RSD of 2.3% （ n = 9）. The unqualified rate of 14 batches of samples was 42.86%. CONCLUSION The method is simple, accurate and reproducible. It can be used in the quality control of this preparation.

关 键 词：盐酸赛庚啶片 溶出度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]