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

作　　者：周钢 马方圆 单莲莲 柴冰阳 陶虹 严华 ZHOU Gang;MA Fangyuan;SHAN Lianlian;CHAI Bingyang;TAO Hong;YAN Hua(Xinjiang Uygur Autonomous Region Drug Inspection and Research Institute,Urumqi,Xinjiang,China 830054;NMPA Key Laboratory for Quality Control of Traditional Chinese MedicineMedicine,Urumqi,Xinjiang,China 830054;National Institute for Food and Drug Control,Beijing,China 100050)

机构地区：[1]新疆维吾尔自治区药品检验研究院,新疆乌鲁木齐830054 [2]国家药品监督管理局中药<维药>质量控制重点实验室,新疆乌鲁木齐830054 [3]中国药品生物制品检定研究院,北京100050

出　　处：《中国药业》2023年第17期83-86,共4页China Pharmaceuticals

基　　金：国家药品(维药)标准提高课题[(2009)781]。

摘　　要：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.

关 键 词：尿通卡克乃其片 吗啡 高效液相色谱法 含量测定 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0