高效液相色谱法内标法测定盐酸苯环壬酯控释片的含量

Content Determination of Phencynonate Hydrochloride Controlled Release Tablets by HPLC-Internal Standard Method

目的建立测定盐酸苯环壬酯控释片含量的高效液相色谱法内标法。方法选择盐酸地芬尼多为内标物,采用Diamonsil C18柱（250 mm×4.6 mm,5μm）为色谱柱,乙腈-水-磷酸-三乙胺（270∶400∶1.3∶2）为流动相,检测波长为220 nm,流速为1.0 mL/min,柱温为30℃。结果盐酸苯环壬酯质量浓度线性范围是2.0-6.0μg/m L,r=0.999 2,平均回收率为101.3%,RSD为1.63%（n=9）。结论该法结果准确可靠、专属性强,可用于盐酸苯环壬酯控释片的含量测定和质量控制。

Objective To establish a HPLC- internal standard method for the content determination of Phencynonate Hydrochloride Controlled Release Tablets. Methods Difenidol hydrochloride was selected as the internal standard by adopting the Diamonsil C18 column（ 250 mm × 4. 6 mm,5 μm） with the mobile phase of acetonitrile- water- phosphoric acid- triethylamine（ 270 ∶ 400 ∶ 1. 3 ∶ 2）. The detection wavelength was 220 nm. The flow rate was 1. 0 mL / min and the column temperature was 30 ℃. Results Phencynonate hydrochloride showed the good linear relation within the range of 2. 0- 6. 0 μg / mL（ r = 0. 999 2）. The average recovery rate was 101. 3%,RSD = 1. 63%（ n = 9）. Conclusion This method is highly specific, accurate and reliable in the detection results, and available for the determination and quality control of Phencynonate Hydrochloride Controlled Release Tablets.