HPLC测定感冒清胶囊中对乙酰氨基酚和盐酸吗啉胍的溶出度

Dissolution Determination of Acetaminophen and Moroxydine Hydrochloride in Ganmaoqing Capsule by HPLC

目的建立感冒清胶囊中对乙酰氨基酚和盐酸吗啉胍的溶出度测定方法。方法采用桨法,以0.1 mol·L^-1的盐酸溶液为溶出介质,转速为50 r·min^-1,取样时间为30 min。高效液相色谱法采用ZORBAX SB-C18（150 mm×4.6 mm,5μm）色谱柱,以乙腈-0.02 mol·L^-1庚烷磺酸钠溶液（15∶85）为流动相,检测波长为237 nm,流速为1.0 mL·min^-1,柱温为30℃。结果对乙酰氨基酚在4.588×10-2-0.458 8μg内呈良好的线性关系（r=0.999 8）,平均回收率为98.1%,RSD为1.06%（n=9）;盐酸吗啉胍在4.654×10-2-0.465 4μg内呈良好的线性关系（r=0.999 6）,平均回收率为97.9%,RSD为1.09%（n=9）。结论该法简便、准确、可行,能准确测定感冒清胶囊中对乙酰氨基酚和盐酸吗啉胍的溶出度,专属性良好。

OBJECTIVE To establish the method of dissolution determination of acetaminophen and moroxydine hydrochloride in Ganmaoqing capsule. METHODS Paddle apparatus was used with 0.1 mol·L-1 hydrochloric acid solution as the dissolution medium at a speed of 50 r·min-1 and dissolution time limit was 30 min. The analysis was carried out on a ZORBAX SB-C18（150 mm×4.6 mm, 5 μm） column, the mobile phase was composed of acetonitrile-0.02 mol·L^-1 sodium heptanesulfonate（15∶85） at the flow rate of 1.0 mL·min^-1 and the detection wavelength was 237 nm. RESULTS Acetaminophen showed good linearity in the range of 4.588×10-2-0.458 8 μg（r=0.999 8）, the average recovery was 98.1% with RSD of 1.06%（n=9）; moroxydine hydrochloride showed good linearity at the range of 4.654×10-2-0.465 4 μg（r=0.999 6）, the average recovery was 97.9% with RSD of 1.09%（n=9）. CONCLUTION The method is convenient, accurate and practicable. It can be applied to determine the dissolution of the preparations.