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目的对盐酸川芎嗪氯化钠注射液进行质量研究。方法高效液相色谱法用十八烷基硅烷键合硅胶为填充剂;甲醇-1%醋酸钠溶液(45∶55)为流动相,检测波长为295 nm,流速1.0 ml/min,柱温为室温。考查线性、精密度、稳定性等;以参比制剂为对照,检测制剂含量及有关物质限量。结果该法精密度、准确度和线性良好,检测3批制剂质量完全符合要求;制剂在1 a内检测指标无变化。结论本试验所建立的高效液相色谱法方法合理可行,适用于控制盐酸川芎嗪氯化钠注射液产品质量。
Objective To study the quality of ligustrazine hydrochloride and sodium chloride injection. Methods High performance liquid chromatography with octadecylsilane bonded silica as a filler; methanol-1% sodium acetate solution (45:55) as the mobile phase, the detection wavelength of 295 nm, the flow rate of 1.0 ml / min, column temperature Room temperature. Check the linearity, precision, stability, etc .; with reference to the preparation as a control, test the content of the formulation and related substances limit. Results The precision, accuracy and linearity of the method were good. The quality of the three batches of preparations was fully tested. No change was detected in the indexes of the preparations within 1 year. Conclusion The HPLC method established in this study is reasonable and feasible and is suitable for controlling the quality of Ligustrazine Hydrochloride Sodium Chloride Injection.