高效液相色谱法测定硼黄栓中盐酸苯海拉明和呋喃唑酮的含量

HPLC in Application of Detection for Diphenhydramine Hydrochloride and Furazolidone Contents in Penghuang Suppository

目的 建立硼黄栓中盐酸苯海拉明和呋喃唑酮的含量测定方法。方法 采用高效液相色谱(HPLC)法分别测定盐酸苯海拉明和呋喃唑酮的含量,色谱柱均为AgilentZorbaxSB-C18(250mm×4.6mm,5μm),流动相分别为乙腈-0.035mol/L磷酸二氢钾溶液(含1%三乙胺,磷酸调节pH3.5±0.1,26∶74)、乙腈-0.035mol/L磷酸二氢钾溶液(15∶85),流速为1.0ml/min,检测波长分别为230nm和364nm。结果 盐酸苯海拉明和呋喃唑酮分别在4.04~40.41μg/ml和1.00~12.01μg/ml范围内线性关系良好(r>0.9999),平均回收率分别为98.41%、100.53%,相对标准偏差分别为1.58%、1.01%。结论 HPLC法操作简便、结果准确、重现性好,可作为控制硼黄栓质量方法。

Objective To establish determination method for Diphenhydramine Hydrochloride and Furazolidone contents in Penghuang suppository. Methods High performance liquid chromatography (HPLC) method was used to respectively detect Diphenhydramine Hydrochloride and Furazolidone in Penghuang suppository. Chromatographic separations were both performed on a Agilent Zorbax SB-C18 (250 mm×4.6 mm, 5 μm) column, and the mobile phase were composed of Acetonitrile and -35 mmol/L potassium dihydrogen phosphate solution (1% Triethylamine, pH3.5±0.1,26∶74) and Acetonitrile and -35 mmol/L potassium dihydrogen phosphate solution (15∶85) respectively at a1.0 ml/min flow rate. Detection wavelengthes were230 nm and364 nm respectively. Results The Diphenhydramine Hydrochloride and Furazolidone showed good linear correlation in a range of 4.04-40.41 μg/ml and1.00- 12.01 μg/ml respectively ( r >0.9 999). The average recoveries of the two compounds were 98.41% and100.53% with relative standard deviations of1.58% and1.01% for Diphenhydramine Hydrochloride and Furazolidone respectively. Conclusion HPLC method is easy to operate with accurate results and good reproducibility, and therefore it can be used for controlling quality of Penghuang suppository.