高效液相色谱法测定尿通卡克乃其片中吗啡含量

Content Determination of Morphine in Niaotongkakenaiqi Tablets by HPLC

目的建立测定尿通卡克乃其片中吗啡含量的高效液相色谱法。方法色谱柱为岛津Shim-pack GIST-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.05 mol/L磷酸氢二钾溶液-0.025 mol/L庚烷磺酸钠溶液(15∶45∶40,V/V/V),流速为1.0 mL/min,检测波长为220 nm,柱温为35℃,进样量为10μL。结果吗啡的质量浓度在3.979~198.950μg/mL范围内与峰面积线性关系良好(r=0.9999,n=6);检测限为1μg/mL,定量限为3μg/mL;精密度、稳定性、重复性试验结果的RSD均小于2.5%(n=6);平均加样回收率为102.77%,RSD为3.84%(n=9)。10批样品中吗啡的平均含量为每片0.32 mg。结论该方法操作简便、结果准确,可用于尿通卡克乃其片中吗啡的含量测定。

Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of morphine in Niaotongkakenaiqi Tablets.Methods The chromatographic column was Shimadzu Shim-pack GIST-C_(18) column(250 mm×4.6 mm,5µm),the mobile phase was acetonitrile-0.05 mol/L dipotassium phosphate solution-0.025 mol/L heptane sulfonate sodium solution(15∶45∶40,V/V/V),the flow rate was 1.0 mL/min,the detection wavelength was 220 nm,the column temperature was 35℃,and the injection volume was 10µL.Results The linear range of morphine was 3.979-198.950µg/mL(r=0.9999,n=6).The limit of detection was 1µg/mL,and the limit of quantitation was 3µg/mL.The RSDs of precision,stability,and repeatability test results were all lower than 2.5%(n=6).The average recovery of morphine was 102.77%with an RSD of 3.84%(n=9).The average content of morphine in 10 batches of samples was 0.32 mg per tablet.Conclusion The method is simple and accurate,which can be used for the content determination of morphine in Niaotongkakenaiqi Tablets.