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目的建立HPLC法测定西咪替丁注射液的含量及有关物质。方法采用HPLC法,色谱条件:SHIMADZU shim-pack C18色谱柱;流动相为甲醇-0.05mol/L己烷磺酸钠溶液,磷酸调节pH2.7(25:75);检测波长:219nm;流速:1ml·min-1。结果西咪替丁在6.512～130.24μg·ml-1的浓度范围内与峰面积呈良好的线性关系(r=0.9999),最低检出限为0.1μg/ml,3个浓度的回收率分别为100.4%,100.1%,99.7%;RSD分别为0.54%、0.21%,0.35%。结论本方法专属性好,准确、灵敏,适用于西咪替丁注射液的含量及有关物质的测定,结果可靠。
Objective To establish HPLC method for the determination of cimetidine injection and its related substances. Methods The HPLC method was used. The chromatographic conditions were as follows: SHIMADZU shim-pack C18 column; the mobile phase was methanol-0.05mol / L sodium hexanesulfonate solution; the pH was adjusted to pH7.7 with phosphoric acid; the detection wavelength was 219nm; 1ml · min-1. Results The concentration of cimetidine in the range of 6.512 ~ 130.24μg · ml-1 showed a good linear relationship with the peak area (r = 0.9999), the lowest detection limit was 0.1μg / ml. The recoveries of three concentrations were 100.4%, 100.1% and 99.7% respectively; RSD was 0.54%, 0.21% and 0.35% respectively. Conclusion The method is specific, accurate and sensitive. It is suitable for the determination of cimetidine injection and its related substances with reliable results.