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目的:建立谷胱甘肽滴眼液的HPLC含量测定方法。方法:色谱条件为:C_(18)柱(150mm×4.6mm,10μm),流动相:0.01 mol·L~(-1)磷酸二氢钾溶液—乙腈(85:15)(其中含戊烷磺酸钠0.01mmol·L~(-1),用磷酸调pH值至2.5,间苯二酚为内标物,检测波长:210nm,流速:0.8ml·min~(-1),测定温度:35℃。结果:谷胱甘肽浓度在10～300mg·L~(-1)之间时,其与内标物的浓度比和其相应的峰面积比呈良好的线性关系,回归方程为:Y=7.0197X—8.3200×10~(-3),r=0.9999。对照品的峰面积与内标物的峰面积比的相对标准偏差为0.86％(n=6)。被测溶液在24h内与内标物的峰面积之比值基本不变。结论:本方法简便,灵敏,准确,可靠。
Objective: To establish a HPLC method for the determination of glutathione eye drops. METHODS: Chromatographic conditions were as follows: C 18 column (150 mm × 4.6 mm, 10 μm), mobile phase: 0.01 mol·L -1 potassium dihydrogen phosphate solution - acetonitrile (85:15) 0.01mmol·L ~ (-1) sodium hypochlorite, the pH was adjusted to 2.5 with phosphoric acid and resorcinol was used as the internal standard. The detection wavelength was 210nm, the flow rate was 0.8ml · min -1, the temperature was 35 ℃ .Results: When the concentration of glutathione was between 10 and 300 mg · L -1, the concentration ratio of glutathione to the internal standard had a good linear relationship with the corresponding peak area ratio, and the regression equation was: Y = 7.0197X-8.3200 × 10 -3, r = 0.9999. The relative standard deviation (RSD) was 0.86% (n = 6) for the peak area of the reference standard and the peak area ratio of the internal standard. The ratio of peak area of internal standard substance is basically the same.Conclusion: The method is simple, sensitive, accurate and reliable.