高效液相色谱法内标法测定盐酸苯环壬酯控释片的含量

摘要

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 / mL，r =0.9992，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 Con-trolled 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 detec-tion wavelength was 220 nm. The flow rate was 1. 0 mL / min and the column temperature was 30 ℃. Results Phencynonate hydrochlo-ride 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.