HPLC法同时测定速克感冒胶囊中5种成分的含量

Simultaneous determination of five components in Suke Ganmao capsules by HPLC

目的:建立高效液相色谱法同时测定速克感冒胶囊中绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素。方法:采用Venusil XBP C_(18)色谱柱(4.6 mm×250 mm,5μm),以乙腈(A)-0.5%磷酸溶液(B)为流动相,梯度洗脱,流速1.0 mL·min^(-1),检测波长327 nm(绿原酸)、260 nm(氯苯那敏)、276 nm(乙酰水杨酸)、334 nm(蒙花苷)和266 nm(次野鸢尾黄素)。结果:5种待测成分分离度良好,阴性无干扰;绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素进样量分别在0.078~0.388μg(r=0.999 9)、0.196~0.978μg(r=0.999 7)、4.066~20.332μg(r=0.999 9)、0.165~0.825μg(r=0.999 9)和0.048~0.238μg(r=0.999 0)范围内线性关系良好;平均回收率分别为96.8%、101.2%、96.8%、100.0%和101.3%,RSD分别为1.8%、2.4%、1.1%、1.9%和3.9%。3批样品中绿原酸、马来酸氯苯那敏、乙酰水杨酸、蒙花苷和次野鸢尾黄素的平均含量分别为0.88~1.00、2.05~2.20、110.02~116.00、2.18~2.45和0.06~0.10 mg·粒^(-1)。结论:该方法可作为评价和监控速克感冒胶囊质量的方法。

Objective： To establish an HPLC method for simultaneous determination of chlorogenic acid, chlorphenamine maleate, acetylsalicylic acid, linarin, and irisflorentin in Suke Ganmao capsules. Methods ： The chromatographic separations were performed on a Venusil XBP ClS column （ 4.6 mm× 250 ram, 5 μm ） , with the mobile phase consisting of aeetonitfile （ A ） -0.5% phosphoric acid （ B ） in gradient elution mode with the flow rate of 1.0 mL· min-1. The UV detection wavelength was set at the maximum absorption wavelength of 327 nm for neochlorogenicacid, 260 nm for chlorphenamine, 276 nm for acetylsalicylic acid, 334 nm for linarin, and 266 nm for irisflorentin. Results- The analytes were separated perfectly by chromatography without disturbing peaks from negative samples. The linear ranges of chlorogenic acid, chlorphenamine maleate, acetylsalicylie acid, linarin, and irisflorentin were 0.078-0.388 μg（ r=0.999 9 ）, 0.196-0.978 μg（ r=0.999 7 ）, 4.066-20.332 μg（ r=0.999 9 ）, 0.165-0.825 μg （ r=0.999 9 ）, and 0.048-0.238 μg （ r=0.999 0 ）, respectively. The average recovery rates of the analytes above were 96.8%, 101.2%, 96.8%, 100.0% and 101.3%, with RSDs of 1.8%, 2.4%, 1.1%, 1.9% and 3.9%, respectively. The determination results of 3-batch samples were as follows： in each capsule of Suke Ganmao capsule, the contents of ehlorogenic acid, chlorphenamine maleate, aeetylsalieylic acid, linarin, and irisflorentin were 0.88-1.00 rag, 2.05-2.20 mg, 110.02-116.00 mg, 2.18-2.45 mg and 0.06-0.10 mg, respectively. Conclusion： The method can be used for the evaluation and quality control of Suke Ganmao capsules.