中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
4期
268-270,287
,共4页
超高效液相色谱法%奈韦拉平%含量测定%有关物质
超高效液相色譜法%奈韋拉平%含量測定%有關物質
초고효액상색보법%내위랍평%함량측정%유관물질
UPLC%Nevirapine%assaying%related substance
目的：：改进奈韦拉平的含量和有关物质测定方法。方法：采用 Acquity UPLC TSS T3 C18(2．1 mm ×50 mm,1．8μm),流动相为10 mmol·L-1磷酸二氢铵溶液(pH 5．0)-乙腈(80∶20),流量为0．7 mL·min-1,检测波长为220 nm。结果：奈韦拉平在0．16~0．96 mg·mL-1的范围内线性关系良好(r=0．999,n=6),平均回收率为99．6%,RSD=2．0%(n=9)。结论：本方法快速、简便、准确,专属性强。
目的：：改進奈韋拉平的含量和有關物質測定方法。方法：採用 Acquity UPLC TSS T3 C18(2．1 mm ×50 mm,1．8μm),流動相為10 mmol·L-1燐痠二氫銨溶液(pH 5．0)-乙腈(80∶20),流量為0．7 mL·min-1,檢測波長為220 nm。結果：奈韋拉平在0．16~0．96 mg·mL-1的範圍內線性關繫良好(r=0．999,n=6),平均迴收率為99．6%,RSD=2．0%(n=9)。結論：本方法快速、簡便、準確,專屬性彊。
목적：：개진내위랍평적함량화유관물질측정방법。방법：채용 Acquity UPLC TSS T3 C18(2．1 mm ×50 mm,1．8μm),류동상위10 mmol·L-1린산이경안용액(pH 5．0)-을정(80∶20),류량위0．7 mL·min-1,검측파장위220 nm。결과：내위랍평재0．16~0．96 mg·mL-1적범위내선성관계량호(r=0．999,n=6),평균회수솔위99．6%,RSD=2．0%(n=9)。결론：본방법쾌속、간편、준학,전속성강。
Objective:To establish an UPLC method for determination of Nevirapine and related substances. Method:The assay was performed on an Acquity UPLC TSS T3 C18 column (2. 1 mm × 50 mm,1. 8 μm) with the mobile phase of 10 mmol·L-1 ammonium dihydrogen phosphate (pH 5. 0)-acetonitrile (80∶20). The flow rate was 0. 7 mL·min-1 and the detection wavelength was 220 nm. Results:The linear response range of Nevirapine was 0. 16-0. 96 mg·mL-1(r=0. 999, n=6), the average recovery was 99. 6%with RSD of 2. 0%(n=9). Conclusion:The method is rapid,simple, accurate and specific.
