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羟乙基淀粉130/0.4注射液中乳酸钠质量研究

Study on Quality of Sodium Lactate Injection in Hydroxyethyl Starch 130/0.4
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摘要 建立高效液相色谱法测定羟乙基淀粉130/0.4乳酸钠林格注射液中乳酸钠含量的方法并考察样品的稳定性。采用thermo BDS HYPERSIL C18(25 cm×4.6 mm,5μm),流动相为0.39%磷酸二氢钾(pH=2.0)∶乙腈,梯度洗脱,检测波长210 nm。结果表明,乳酸钠在0.185~1.235 mg·m L^-1范围内线性关系良好,r=0.9998,样品中乳酸钠平均含量为0.588 mg·m L^-1,长期稳定性实验乳酸钠含量稳定。该方法能够准确的测定羟乙基淀粉130/0.4注射液中乳酸钠含量,复方注射液稳定性良好。 The HPLC method for determination the content of sodium lactate in hydroxyethyl starch 130/0. 4 was established and the stability of the sample was investigated. Thermo BDS HYPERSIL C18( 25 cm×4. 6 mm,5 μm),mobile phase 0. 39% potassium dihydrogen phosphate( pH = 2. 0) ∶ acetonitrile and program of gradient elution were used,and detection wavelength was 210 nm. Results indicated that sodium lactate maintained fine linear relationship in the concentration range of 0. 185 ~ 1. 235 mg · m L^-1,r = 0. 9998,the content of sodium lactate in the samples was0. 588 mg·m L^-1,long-term stability of the experimental results were stable. The methods could accurately determine the content of sodium lactate in hydroxyethyl starch 130/0. 4 injection and the stability of the compound injection was good.
出处 《广州化工》 CAS 2016年第20期111-113,共3页 GuangZhou Chemical Industry
关键词 羟乙基淀粉130/0.4 乳酸钠 稳定性 hydroxyethyl starch130/0.4 sodium lactate stability
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