高效液相色谱法同时测定复方地芬诺酯片中两组分含量

Simultaneous Determination of Diphenoxylate Hydrochloride and Atropine Sulfate in Compound Diphenoxylate Tablets by HPLC

目的建立同时测定复方地芬诺酯片中盐酸地芬诺酯和硫酸阿托品含量的高效液相色谱(HPLC)法。方法色谱柱为岛津VP-ODS柱(150mm×4.6mm,5μm),流动相为0.5%十二烷基硫酸钠溶液(用70%磷酸调节pH至2.7)-乙腈(35∶65),检测波长210nm,柱温30℃,流速1.0mL/min。结果盐酸地芬诺酯和硫酸阿托品质量浓度线性范围分别为10.12～505.6μg/mL(r=0.9999)和2.36～118.0μg/mL(r=0.9999),平均回收率分别为100.17%(RSD=1.22%)和99.43%(RSD=0.84%)。结论方法简便快速,结果准确可靠,可作为该复方制剂中两组分的质量控制方法。

Objective To establish a method for the simultaneous determination of two constituents in Compound Diphenoxylate Tablets. Methods The chromatographic VP- ODS column （t50 mm ×.6 mm, 5 μm） was used. The mobile phase consisted of 0. 5% sodium dodecyl sulfate （adjusting to pH=2. 7 with 70% phosphoric acid） -acetonitrile （35：65） and the flow rate was 1.0mL/min. The detection wavelength was 210 nm. The column temperature was 30 ℃. Results The linear response ranges were 10. 12-505.6 μg/mL for diphenoxylate hydrochloride （r=0. 999 9） and 2.36- 118.0 μg/mL for atropine sulfate（ r =0. 999 9） respectively. The mean recovery rates of diphenoxylate hydrochloride and atropine sulfate were 100. 17% （RSD = 1.22% ） and 99.43% （RSD =0. 84% ） respectively. Conclusion This method is simple and quick with accurate and reliable result, which is suitable for the determination of the two constituents in this compound preparation.