中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
14期
58-60
,共3页
高效液相色谱法%盐酸瑞伐拉赞%有关物质
高效液相色譜法%鹽痠瑞伐拉讚%有關物質
고효액상색보법%염산서벌랍찬%유관물질
high performance liqnid chromatography(HPLC)%revaprazan hydrochloride%related substances
目的：建立测定盐酸瑞伐拉赞有关物质含量的高效液相色谱法。方法色谱柱采用 Inertsil - C8柱（250 mm ×4.6 mm，5μm），以0.01 mol / L 磷酸氢二钠溶液（用磷酸调节 pH 至4.0）-乙腈（30：70）为流动相，检测波长为205 nm，流速为1.0 mL / min，柱温为35℃，进样量为10μL，稀溶液自身对照法进行定量。结果盐酸瑞伐拉赞的检测限为0.09μg / mL（ S / N =3），定量限为0.30μg / mL（ S / N =10）；稀溶液质量浓度在0.3~6μg / mL 范围内与峰面积呈良好线性关系，线性回归方程为 A =2.1866+41.9402 C，r =0.9998( n =6)。结论该方法专属性好、准确度高，适用于盐酸瑞伐拉赞有关物质的含量测定。
目的：建立測定鹽痠瑞伐拉讚有關物質含量的高效液相色譜法。方法色譜柱採用 Inertsil - C8柱（250 mm ×4.6 mm，5μm），以0.01 mol / L 燐痠氫二鈉溶液（用燐痠調節 pH 至4.0）-乙腈（30：70）為流動相，檢測波長為205 nm，流速為1.0 mL / min，柱溫為35℃，進樣量為10μL，稀溶液自身對照法進行定量。結果鹽痠瑞伐拉讚的檢測限為0.09μg / mL（ S / N =3），定量限為0.30μg / mL（ S / N =10）；稀溶液質量濃度在0.3~6μg / mL 範圍內與峰麵積呈良好線性關繫，線性迴歸方程為 A =2.1866+41.9402 C，r =0.9998( n =6)。結論該方法專屬性好、準確度高，適用于鹽痠瑞伐拉讚有關物質的含量測定。
목적：건립측정염산서벌랍찬유관물질함량적고효액상색보법。방법색보주채용 Inertsil - C8주（250 mm ×4.6 mm，5μm），이0.01 mol / L 린산경이납용액（용린산조절 pH 지4.0）-을정（30：70）위류동상，검측파장위205 nm，류속위1.0 mL / min，주온위35℃，진양량위10μL，희용액자신대조법진행정량。결과염산서벌랍찬적검측한위0.09μg / mL（ S / N =3），정량한위0.30μg / mL（ S / N =10）；희용액질량농도재0.3~6μg / mL 범위내여봉면적정량호선성관계，선성회귀방정위 A =2.1866+41.9402 C，r =0.9998( n =6)。결론해방법전속성호、준학도고，괄용우염산서벌랍찬유관물질적함량측정。
Objective To establish a high performance liqnid chromatography(HPLC) method for determining the content of related sub-stances in revaprazan hydrochloride. Methods The Inertsil - C8 column(250 mm × 4. 6 mm,5 μm)was adopted with the mobile phase of 0. 01 mol / L disodium hydrogen phosphate(DSP)solution(adjusting pH = 4. 0 with phosphoric acid)- acetonitrile(30 : 70)at a flow rate of 1. 0 mL / min. The detection wavelength was set at 205 nm. The column temperature was set at 35 ℃. The sample size was 10 μL with the dilute solution self - control method for conducting the quantitative determination. Results The limit of detection(LOD) and limit of quantitation(LOQ)were 0. 09 μg / mL( S / N = 3) and 0. 3 μg / mL( S / N = 10) respectively. The dilute solution exhibited a good linearity in the concentration range of 0. 3 - 6 μg / mL(the linear equation was A = 2. 186 6 + 41. 940 2 C,r = 0. 999 8( n = 6). Conclusion This method has good specificity which high accuracy,and can be suitable for the determination of the related substances in revaprazan hydrochloride.
