高效液相色谱法测定注射用唑来膦酸的含量
Determination of zoledronic acid for injection by HPLC
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摘要: 目的 用反相离子对高效液相色谱法测定注射用唑来膦酸的含量。方法 以DiamonsiL C18(250mm×4.6mm,51μm)柱为分析柱,乙腈-离子对缓冲盐(含0.02mmoL/mL的四丁基氢氧化铵和磷酸二氢铵,并用50%的磷酸溶液调节pH至2.3)(25:75)为流动相,检测波长为210nm。结果 唑来膦酸浓度在50-240μg/mL范围内峰面积与浓度线性关系良好(r=1.0);平均回收率为100.0%,RSD为0.4%。结论 本方法准确、简便、快速,适用于测定唑来膦酸的含量。Abstract: OBJECTIVE To establish an HPLC method for the determination of zoledronic acid for injection. METHOD:The analysis was achieved by using Diamonsil C18 column with acetonitrile-ion-pair buffer solution(25:75)as mobile phase and UV-detector at wavelength 210nm. The ion-pair buffer solution was a mixture of 0.02mmo1/mL tetrabutyl ammonium hydroxide and 0.02mmo1/mL ammonium dihydrogen phosphate adjusted pH 2.3 with 50% phosphoric acid RESULTS:The linear range was from 50 to 240μg/mL(r=1.0). The average recovery was 100.0%(RSD=0.4%).CONCLUSIONS This method is simple,sensitive,accurate and suitable for the determination of zoledronic acid for injection.
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Key words:
- zoledronic acid for injection /
- determination /
- HPLC
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