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目的:建立HPLC法测定氢溴酸樟柳碱原料及其制剂的含量测定方法。方法:采用Agilent HC-C8色谱柱(250mm×4.6mm,5μm);流动相为磷酸盐缓冲液(取磷酸二氢钾1.36g,庚烷磺酸钠4.04g,三乙胺5.0mL,加水1 000mL,用磷酸调节pH至3.0)-甲醇(65:35);柱温35℃;流速为1.0mL·min-1;紫外检测波长为210nm。结果:氢溴酸樟柳碱在2～200mg·L-1范围内线性关系良好,r=0.999 9(n=7);各种制剂的回收率均在98.0%～102.0%之间。结论:本测定方法准确、灵敏、专属性高,可作为氢溴酸樟柳碱及其制剂的含量测定方法。
Objective: To establish a method for the determination of anisodine hydrobromide and its preparation by HPLC. Methods: Agilent HC-C8 column (250mm × 4.6mm, 5μm) was used. The mobile phase consisted of phosphate buffer (1.36g, potassium heparate, 4.04g, triethylamine, 000mL, adjust the pH to 3.0 with phosphoric acid) -methanol (65:35); the column temperature was 35 ℃; the flow rate was 1.0mL · min-1; UV detection wavelength was 210nm. Results: The linear range of anisodine hydrobromide was in the range of 2 ~ 200 mg · L-1, r = 0.999 9 (n = 7). The recoveries of various formulations ranged from 98.0% to 102.0%. Conclusion: The method is accurate, sensitive and specific. It can be used as the method for the determination of anisodine hydrobromide and its preparations.