HPLC测定小儿对乙酰氨基酚异丙嗪片的含量

Determination the Content of Pediatric Paracetamol and Promethazine Tablets by HPLC

目的建立测定小儿对乙酰氨基酚异丙嗪片含量的高效液相色谱法。方法以Phenomenex Luna C18（4．6mm×250mm，5μm）为色谱柱，甲醇-5mmol·L^-1己烷磺酸钠溶液-冰醋酸-三乙胺（68：31．3：0．64：0．03）为流动相，流速为1．0mL·min^-1，检测波长为306nm，进样量20μL。结果对乙酰氨基酚线性范围为0．9297—4．648mg·mL^-1，r=0．9999，平均回收率为99．96％（RSD=1．2％，n=9）；盐酸异丙嗪线性范围为38．72—193．6μg·mL^-1，r=0．9999，平均回收率为99．38％（RSD=1．2％，n=9）。结论本法简便快速、准确可靠，可用于测定小儿对乙酰氨基酚异丙嗪片含量。

OBJECTIVE To establish an assay method for pediatric paracetamol and promethazine tablets by HPLC. METHODS The chromatographic conditions are listed as follow： Phenomenex Luna C18 （4. 6 mm × 250 mm ,5 μm）was used as the column. The mobile phase consisted of methanol-5 mmol · L^ - 1 sodium hexanesulfonate solution-acetic acid glacial-triethylamine （ 68 ： 31.3 ： 0.64： 0. 03 ）. The flow rate was 1.0 mL · min^-1, and the UV detection wavelength was 306 nm,20 μL was injected. RESULTS The curve of paracetamol was linear within 0. 929 7 - 4. 648 mg · mL^- 1, r = 0. 999 9, the average recovery was 99. 96% （ RSD = 1.2% n = 9 ）. The curve of promethazine hydrochloride was linear within 38, 72 - 193.6 μg · mL^-1 ,r =0. 999 9, the average recovery was 99. 38% （RSD = 1.2% ,n =9）. CONCLUSION The method is accurate, simple and rapid, and it can be used to determine the pediatric paracetamol and promethazine tablets.