离子色谱法测定葡萄糖酸钙(锌)制剂的含量

QUANTITATIVE DETERMINATION OF CALCIUM (ZINC) GLUCONATE IN PREPAPATIONS BY ION CHROMATOGRAPHY

采用Waters ILC-1离子液相色谱仪,IC-PAK A 50 mm×4.6 mm色谱柱,pH 6.1的1×10^(-3)mol/L邻苯二甲酸溶液为流动相,430型电导检测器检测,由外标法和外标单点校正法测定了葡萄糖酸钙片和葡萄糖酸锌片的含量。方法简便、快速,测定结果与中国药典法一致。外标法和外标单点校正法测定葡萄糖酸钙注射液的回收率分别为98.85%和99.59%,相关系数分别为0.9901(n=4)和0.9911(n=4)。外标单点校正法测定葡萄糖酸钙片和葡萄糖酸锌片的回收率分别为101.3%和101.4%,相关系数分别为0.9968(n=4)和0.9928(n=4)。

Ion chromatographic determination of calcium gluconate injection (A), calcium gluconatc tablets (B) and zinc gluconate tablets (C) was studied. Waters ILC-I Ion/Liquid chromatograph, IC-PAK A 50 mm×4.6 mm ID column was used, pH 6.1, 1×10-3tool/L phthalic acid as mobile phase at a flow rate of 1.0 ml/min, 430 model conductivity detector with 2.5 μs FS. The recoveries of external standard method (Ⅰ) and external standard single-point calibration method (Ⅱ) for the determination of A were 98.85% and 99.59%, and the correlation coefficients were 0.9901 (n=4) and 0.9911 (n=4) respectively. The recoveries of method Ⅱ for the determination of B and C were 101.4% and 101.3%, and the correlation coefficients wcre 0.9968 (n=4) and 0.9928 (n=4) respectively. The results obtained by method Ⅰ, mcthod Ⅱ and Chincsc Pharmacopocia method (Ⅲ) wcrc in good agreement. However, method Ⅱ was more simplc, rclativcly fast and more practical.