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

关键词:  感冒清胶囊  对乙酰氨基酚  盐酸吗啉胍  高效液相色谱法

Key words:  Ganmaoqing capsule  acetaminophen  moroxydine hydrochloride  HPLC

摘要:

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，5 μm)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 8 μg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 4 μg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。

Abstract:

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 Acetamino- phen 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.