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目的:建立HPLC法测定盐酸吗啉胍注射液中有关物质及含量。方法:采用反相高效液相色谱法,固定相为十八烷基硅烷键合硅胶(150mm×4.6mm,5μm),流动相为0.02mol·L-1庚烷磺酸钠溶液-甲醇-乙腈(85∶5∶10),流速1.0mL·min-1,检测波长237nm。结果:盐酸吗啉胍在1.002～200.40μg·mL-1的浓度范围内与峰面积呈良好的线性关系(r=0.9999),最低检测限为0.1μg·mL-1。高、中、低3种浓度的平均回收率分别为98.9%,101.3%,100.7%;RSD分别为1.8%,1.0%,1.4%。结论:该方法专属性好,准确、灵敏,用于盐酸吗啉胍注射液的含量及有关物质的测定结果可靠。
Objective: To establish a HPLC method for the determination of related substances and content in Moroxydine Hydrochloride Injection. Methods: The reversed-phase high performance liquid chromatography (RP-HPLC) was used. The stationary phase was octadecylsilane bonded silica gel (150 mm × 4.6 mm, 5 μm) with a mobile phase of 0.02 mol·L -1 sodium heptanesulfonate solution (85: 5:10), flow rate 1.0mL · min-1, detection wavelength of 237nm. Results: Moroxydine hydrochloride showed a good linear relationship with the peak area (r = 0.9999) in the concentration range of 1.002 ~ 200.40μg · mL-1 with the detection limit of 0.1μg · mL-1. The average recoveries of high, medium and low concentrations were 98.9%, 101.3% and 100.7%, respectively. The RSDs were 1.8%, 1.0% and 1.4% respectively. Conclusion: The method is specific, accurate and sensitive. The method for the determination of morphine guanidine hydrochloride injection and its related substances is reliable.