目的 建立米格列奈钙中6种有机溶剂残留量的分离测定方法 。方法 采用溶液直接进样气相色谱法，色谱柱为Porapak Q填充柱（2 m×3 mm），载气为氮气，以二甲基亚砜为溶剂，测定了米格列奈钙原料药中甲醇、乙醇、二氯甲烷、四氢呋喃、乙酸乙酯与异丙醚的残留量。结果 6种有机溶剂完全分离，在所考察的浓度范围内线性关系良好，其中甲醇的线性范围在0.306 8～30.68 mg·L^-1 (r=0.999 97)，乙醇的线性范围在0.4964～49.64 mg·L^-1(r=0.999 9)，二氯甲烷的线性范围在0.060 2～6.02 mg·L^-1(r=0.999 5)，四氢呋喃的线性范围在0.071 5～7.15 mg·L^-1(r=0.999 9)，乙酸乙酯的线性范围在0.502 3～50.23 mg·L^-1(r=0.999 9)，异丙醚的线性范围在0.494 5～49.45 mg·L^-1(r=0.999 8)。各残留溶剂的精密度实验RSD均小于5%，平均回收率在94.73%～105.47%之间。结论 本实验所建立的方法 简便、灵敏、准确，可用于米格列奈钙中有机溶剂残留量的测定。

OBJECTIVE To develop a method for the determination of six organic residual solvents in mitiglinide calcium. METHODS The residual organic solvents including methanol, ethanol, dichloromethane, tetrahydrofuran, ethyl acetate and isopropyl ether were quantitatively determined by GC on a Porapak Q（2 m×3 mm） column. DMSO was solvent media, nitrogen was the carrier gas. RESULTS Six residual organic solvents were completely separated. The linear range of methanol was 0.306 8-30.68 mg·L-1 (r=0.999 9), the linear range of ethanol was 0.496 4-49.64 mg·L-1 (r=0.999 9), the linear range of dichloromethane was 0.060 2-6.02 mg·L-1 (r=0.999 5), the linear range of tetrahydrofuran was 0.071 5-7.15 mg·L-1 (r=0.999 9), the linear range of ethyl acetate was 0.502 3-50.23 mg·L-1 (r=0.999 9), the linear range of isopropyl ether was 0.494 5-49.45 mg·L-1(r=0.999 8). The RSDs of precision of six residual organic solvents were less than 5%, the average recovery rates of the preparationwere in the range of 94.73%-105.47%. CONCLUSION The method is simple, sensitive, accurate and can be used for the quality control of mitiglinide calcium.