文档介绍：UPLC法测定醋酸阿托西班注射液含量
摘要:目的 建立测定醋酸阿托西班注射液含量的UPLC法并进行方法学验证。方法 色谱条件:,乙***为流动相B,梯度洗脱;进样量2μl,流速0o interference with this method. The RSD of repeatability was %, the RSD of the intermediate precision was %, and RSD of the solution stability test was %. The average recovery rate of different spike quantities was %. The robustness results revealed that the RSD of the test results under different conditions was within %. HPLC and UPLC were adopted to compare the assay of 3 batches of sample, and the relative deviations of the two methods were both not more than %. Conclusions UPLC method was rapid, simple and convenient, accurate and had strong specificity, and it was suitable for assay of Atosiban Acetate Injection.
Key Words;Atosiban Acetate Injection ;UPLC; Content
引言
醋酸阿托西班是催产素拮抗剂,代表一种新的抗分娩药【1】。醋酸阿托西班注射液能有效抑制宫缩,无明显副作用,是治疗先兆早产有效而安全的方法。【2】目前国内采用HPLC测定其含量和有关物质,其方法检测时间长,化学试剂用量大,本文参照HPLC含量测定方法建立其含量UPLC测定法。
1 材料
【样品与对照品】醋酸阿托西班注射液(20180602、20180603、20180701),工作对照品(S01820171101)海南中和药业股份有限公司制。
【主要试剂及仪器】CQUITY UPLC H-Class型超高效液相色谱仪,ACQ TUV 紫外检测器;waters C18 x 50 mm,;磷酸二氢钾(广州化学试剂厂 AR)、磷酸(成都市科隆化学品有限公司2017060501、AR)、三乙***(西陇化工股份有限公司110722、AR)、乙***(上海星要可高纯溶剂有限公司011471201、色谱纯)
【色谱条件】(,加水1000ml,,再加入120μl三乙***,即得)为流动相A,乙***为流动相B,线性梯度洗脱;;检测波长为215nm。同时精密称取醋酸阿托西班对照品和杂质A对照品适量