HPLC-RID法测定葡甲胺原料药的含量

Content Determination of Meglumine Raw Material by HPLC-RID

目的：建立测定葡甲胺原料药含量的方法。方法：采用高效液相色谱-示差折光检测法。色谱柱采用月旭Ultimate AQ-C18，流动相为水（pH2．5）-甲醇（95：5），流速为0．5ml／min，检测器池温为40℃，柱温为35℃。测定3批样品含量并与《中国药典》方法滴定法结果比较。结果：葡甲胺检测质量浓度线性范围为1．52～4．56mg／ml（r=0．9999），平均回收率为99．7％（RSD=0．63％，n=3）。本文建立的方法与滴定法测定结果一致。结论：建立的方法简便、快速、准确，适用于葡甲胺原料药的含量测定.

OBJECTIVE： To establish the method for the content determination of meglumine. METHODS： HPLC-RID was adopted. The determination was performed on Welch Ultimate AQ-C18 column with mobile phase consisted of water （pH adjusted to 2.5）-methanol （95：5） at the flow rate of 0.5 ml/min. The detector temperature was 40 ℃ and column temperature was 35 ℃. The contents of 3 batches of samples were compared with the results of titration stated in Chinese Pharmacopeia. RESULTS ： The linear range of meglumine were 1.52-4.56 mg/ml （r=0.999 9） with an average recovery of 99.7% （RSD=0.63%, n=3）. The results of the method were consistent with those of titration method. CONCLUSIONS： The method is simple, fast and accurate, and it is suitable for the content determination for meglumine raw material.