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目的:测定左旋盐酸苯环壬酯片的含量及溶出度。方法:采用溶剂萃取酸性色素比色法(BCG法)测定含量,λmax=414nm。溶出度以桨法测定,转速50r·min-1,溶出介质为250mL0.1mol·L-1盐酸溶液。结果:当左旋盐酸苯环壬酯浓度为2.0～10.0μg·mL-1时,浓度与吸光度呈良好线性,回归方程:Y=0.0935X+0.0021,R2=1(n=3),回收率为(98.76±1.55)%,RSD=1.57%(n=5)。片剂30min取样,主药溶出80%以上。结论:该方法简便、快捷、准确,与HPLC法含量测定结果基本一致,为该制剂的溶出度测定及片剂半成品快速测定提供了方法学依据。
Objective: To determine the content and dissolution of levonorhenate hydrochloride tablets. Methods: Solvent extraction acid colorimetric method (BCG method) determination of content, λmax = 414nm. Dissolution was measured by paddle method, speed 50r · min-1, dissolution medium 250mL0.1mol · L-1 hydrochloric acid solution. Results: When the concentration of levonorhenate was 2.0 ~ 10.0μg · mL-1, the concentration and absorbance showed good linearity. The regression equation was Y = 0.0935X + 0.0021, R2 = 1 (n = 3) (98.76 ± 1.55)%, RSD = 1.57% (n = 5). Tablet 30min sampling, the main drug dissolution of more than 80%. Conclusion: The method is simple, rapid and accurate, and it is basically consistent with the HPLC method. It provides a methodological basis for the determination of the dissolution and the rapid determination of semi-finished tablets.