高效液相色谱法检测马来酸氯苯那敏片的含量

Datetime:2024-07-05 From:


马来酸氯苯那敏片的含量测定

1. 参照依据:

2020版《中国药典》二部第71页下的马来酸氯苯那敏片含量测定,要求理论塔板数按氯苯那敏峰计算不低于4000,氯苯那敏峰与相邻杂质峰之间的分离度应符合要求。

2. 实验结果

    器:S6000 UV;

柱:Alphasil VC-C18, 4.6 × 250 mm, 5 µm, 100Å;

相:A相:磷酸盐缓冲液(取磷酸二氢铵11.5 g,加水适量使溶解,加磷酸1 mL,用水稀释至1000 mL);B相:乙腈;

洗脱条件:A:B=80:20;

    速:1.0 mL/min;

    温:30 ℃;

量:10 μL;

检测波长:262 nm;

图1  马来酸氯苯那敏片含量测定色谱图

(峰号:1,氯苯那敏)

马来酸氯苯那敏片定含量测定结果表

名称

保留时间(min

拖尾因子

USP理论塔板数

USP分离度

1

氯苯那敏

17.41

1.24

8332

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