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目的:采用高效液相色谱法考察并建立了测定复方罗布麻片Ⅰ中盐酸异丙嗪和氯氮(?)含量的方法。方法:色谱柱为Phenomenex-ODS3柱(250 ×4.60mm,5μm),甲醇-磷酸盐缓冲溶液(取磷酸二氢胺2.64g,加水1 000mL溶解后,用磷酸调节pH值至3.0)(55:45)为流动相,流速1.0mL/min,检测波长为250nm,进样量20μL。结果:盐酸异丙嗪的线性范围为5.1-60.8μg/mL(r=1.000 0),氯氮(?)的线性范围为5.2-60.4μg/mL(r=0.999 9),平均回收率分别为99.5％和101.2％。结论:本法精密度好,结果准确可靠,适用于该复方制剂的质量检验分析。
OBJECTIVE: To investigate and establish a method for the determination of promethazine hydrochloride and chloronitrogen (?) In Compound Apocynum I tablets by high performance liquid chromatography. Methods: The chromatographic column was a Phenomenex-ODS3 column (250 × 4.60mm, 5μm). The methanol-phosphate buffer solution (taking 2.64g of diammonium phosphate and dissolving with 1000mL of water) was adjusted to pH 3.0 with phosphoric acid 45) as mobile phase, the flow rate was 1.0 mL / min, the detection wavelength was 250 nm and the injection volume was 20 μL. Results: The linear range of promethazine hydrochloride was 5.1-60.8 μg / mL (r = 1.000 0), and the linear range of chloronitrogen (?) Was 5.2-60.4 μg / mL (r = 0.999 9). The average recoveries were 99.5% and 101.2%. Conclusion: The method has good precision and accurate and reliable results, which is suitable for the quality inspection and analysis of the compound preparation.