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目的建立同时测定小儿氨酚烷胺颗粒中对乙酰氨基酚及盐酸金刚烷胺含量的高效液相色谱-示差折光检测(HPLCRID)法。方法采用Waters Sun Fire C_(18)色谱柱(4.6 mm×150 mm,5μm),流动相为甲醇-水(10∶90,V/V),柱温为30℃,进样量为20μL,流速为1.5 mL·min~(-1),检测器为RID,检测池温度为30℃。结果对乙酰氨基酚的线性范围为0.618 5~4.948 0mg·mL~(-1)(r=0.999 9),平均回收率为99.5%(RSD=1.8%,n=9),盐酸金刚烷胺的线性范围为0.253 2~2.025 6 mg·mL~(-1)(r=0.999 5),平均回收率为100.3%(RSD=1.5%,n=9)。结论本法简便,快速,准确,重现性好,适用于小儿氨酚烷胺颗粒的质量控制。
OBJECTIVE To establish a high performance liquid chromatography coupled with differential refractometry (HPLCRID) method for the simultaneous determination of paracetamol and amantadine hydrochloride in children with paracetamol. Methods A Waters Sun Fire C 18 column (4.6 mm × 150 mm, 5 μm) was used. The mobile phase was methanol-water (10:90, V / V) and the column temperature was 30 ℃. 1.5 mL · min -1, the detector was RID and the cell temperature was 30 ℃. Results The linear range of paracetamol was 0.618 5 ~ 4.948 0 mg · mL ~ (-1) (r = 0.999 9), the average recovery was 99.5% (RSD = 1.8%, n = 9) The linear range was 0.253 2 ~ 2.025 6 mg · mL -1 (r = 0.999 5). The average recovery was 100.3% (RSD = 1.5%, n = 9). Conclusion This method is simple, rapid, accurate and reproducible. It is suitable for the quality control of paracetamol granule in children.