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HPLC法测定甲状旁腺激素(1-34)原料药的含量

Content Determination of PTH (1-34) Raw Material by HPLC
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摘要 目的:建立以高效液相色谱法测定甲状旁腺激素(1-34)原料药含量的方法。方法:色谱柱为Spherisorb ODS;流动相A为甲醇,流动相B为0.05mo·lL-1 Na2SO4水溶液(磷酸调节至pH2.5),A∶B=30∶70;流速为1.0mL·min-1;检测波长为215nm;柱温为室温;进样量为20μL。结果:甲状旁腺激素(1-34)检测浓度线性范围为0.06~0.90mg·mL-1(r=0.99997),平均回收率98.6%,RSD=0.15%。结论:本方法简便、准确、灵敏度高,可用于甲状旁腺激素(1-34)原料药含量的测定。 OBJECTIVE: To develop the HPLC method for the content determination of PTH (1-34). METHODS: The determination was performed on Spherisorb ODS. The mobile phase A consisted of methanol and the mobile phase B consisted of 0.05 moL·L-1 Na2SO4 (pH adjusted to 2.5 by H3PO4, A ∶ B=30 ∶ 70). The flow rate was 1.0 mL·min-1 and the detection wavelength was set at 215 nm. The column temperature was room temperature and injection volume was 20 μL. RESULTS: The linear range of PTH (1-34) was 0.06~0.90 mg·mL^-1 (r=0.999 97) with an average recovery of 98.6%, RSD=0.15%. CONCLUSION: The method is simple, accurate, highly sensitive and suitable for the content determination of raw material of PTH (1-34).
出处 《中国药房》 CAS CSCD 北大核心 2010年第37期3526-3527,共2页 China Pharmacy
关键词 高效液相色谱法 甲状旁腺激素(1-34) 原料药 含量测定 HPLC PTH (1-34) Raw material Content determination
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