HPLC法测定格列齐特片和格列齐特片(Ⅱ)的含量

目的：建立HPLC法测定格列齐特片和格列齐特片（Ⅱ）的含量。方法：采用Phenomenex C18柱（4．6 mm×250mm，5μm），柱温25℃；流动相为0．03mol·L^-1磷酸二氢铵溶液（用磷酸调节pH值至3．0）-甲醇（3：7）；流速为1．0mL·min^-1；检测波长为230nm。分别以外标法计算含量。结果：格列齐特在0．015～0．381 g·L^-1线性关系良好，回归方程Y=2×10^7X＋1．00×10^5，r=0．9996。平均回收率为99，52％和99．36％，RSD为0．63％和0．49％。结论：本方法可用于测定格列齐特片、格列齐特片（Ⅱ）的含量，灵敏度高、操作简便、准确可靠。

Content Determination of Gliclazide Tablets and Gliclazide Tablets by HPLC

Objective： To establish an HPLC method for the determination of Gliclazide Tablets and Gliclazide Tablets（ Ⅱ ）. Method： The column was Phenomenex C18 （4.6 mm×250mm,5μm） , column temperature was 25 ℃ and the mobile phase was 0. 03 mol · L ^-1 Ammonium Dihydrogen phosphate （ adjusted to pH3.0 with phosphoric acid） -methanol = 3： 7, with flow rate 1.0 mL · min ^- 1 and the detective wavelength was 230 nm. The assay of content calculated by external standard method. Results： The linear range of the calibration curve of Glielazide were 0. 015 - 0. 381 g·L^-1 （ r = 0. 999 6 ）, the average recovery was 99. 52% and 99. 36%. The relative standard deviations （n = 6） were 0.63 % and 0. 49%. Conclusion ：It can be used to deterimine the content of the Glielazide Tablets and Glielazide Tablets （ Ⅱ ） , The method is simple, sensitive, accurate and reliable.