HPLC同时测定赖氨葡锌片中葡萄糖酸锌和盐酸赖氨酸的含量

Simultaneous Determination of Zinc Gluconate and Lysine Hydrochloride in Lysine Hydrochloride and Zinc Gluconate Tablet by RP-HPLC

关键词:  高效液相色谱法  葡萄糖酸锌  盐酸赖氨酸  同时测定

Key words:  HPLC  zinc gluconate  lysine hydrochloride  simultaneous determination

摘要:

目的建立赖氨葡锌片剂中葡萄糖酸锌和盐酸赖氨酸含量同时测定的高效液相色谱法。方法以C18色谱柱、0.05 mol·L-1 KH2PO4（pH=3.00）为流动相分离、210 nm紫外检测、外标法定量。结果葡萄糖酸锌的线性范围为0.045 3～5.80 mmol·L-1，L-赖氨酸的线性范围为0.133～17.0 mmol·L-1。方法回收率大于98.0%；日内及日间RSD小于2.0%。结论本方法不经分离直接同时测定赖氨葡锌片剂中葡萄糖酸锌和盐酸赖氨酸的含量，快速、简便、准确，可用于赖氨葡锌片剂的质量控制。

Abstract:

OBJECTIVE To establish a RP-HPLC method for simultaneous determination of zinc gluconate and lysine hydrochloride in lysine hydrochloride and zinc gluconate tablet. METHODS Reverse phase ODS column was used as the stationary phase and 0.05 mol·L-1 KH2PO4 (pH=3.00) was used as mobile phase with 210 nm for detection wavelength. RESULTS The calibration curve was linear over the range of 0.0453-5.80 mmol·L-1 for zinc gluconate and 0.133-17.0 mmol·L-1 for lysine hydrochloride.The recovery was 98.8%～101.9%. The coefficients of variation for within day and between days were all less than 2.0%(n=5). CONCLUSION The method could be easily employed with high precision and accuracy for simultaneous determination of zinc gluconate and lysine hydrochloride in lysine hydrochloride and zinc gluconate tablet without prior separation, and could be used for the quality control in production process of the tablet.