摘要
目的:建立用HPLC法测定复方盐酸阿替卡因注射液中盐酸阿替卡因和肾上腺素两组分含量的方法。方法:采用C_8柱和C_(18)柱分别建立两组分的色谱分离检测系统,其中测定盐酸阿替卡因采用的流动相为含庚烷磺酸钠的乙腈与磷酸盐缓冲液,检测波长为276 nm;测定肾上腺素时采用了水和甲醇双流动相切换洗脱装置,检测波长为220 nm。结果:盐酸阿替卡因的浓度线性范围为4～400μg/mL(r=0．9999),低、中、高3个浓度溶液的加样回收率分别为(103．83±0．85)％、(101．26±0．44)％、(99．15±0．31)％(n=5),日内RSD分别为1．69％、0．60％、0．21％(n=5),日间RSD分别为1．73％、0．67％、0．22％(n=5)。肾上腺素的浓度线性范围为1～100μg/mL(r=0．999 9)。低、中、高3个浓度溶液的加样回收率分别为(102．89±0．85)％、(99．30±0．43)％、(100．39±0．82)％(n=5),日内RSD分别为0．94％、0．71％、0．34％(n=5),日间RSD分别为1．37％、0．96％、0．55％(n=5)。结论:该方法精密、简便、准确,可用于复方盐酸阿替卡因注射液的含量测定。
Objective： To establish a method for determination of articaine hydrochloride and adrenaline in compound articaine hydrochloride injection by HPLC method. Methods.. For the determination of articaine hydrochloride, the column was packed with C8 ,the mobile phase was composed of acetonitrile, phosphate buffer and sodium heptanesulfonate,and the detection wavelength was 276 nm. For adrenaline, the column packed with C18 was eluted alternately by water and methanol through a column switching system,and the detection wavelength was 220 nm. Results.. For articaine hydrochloride, the linear range was 4- 400 μg/mL（r= 0. 999 9）. At low, middle and high concentrations, the recovery rates were （103.83 ± 0. 85 ）%, （101.26 ±0.44）% and （99.15±0.31）% （n=5）,the intra-day RSD were 1.69%,0.60% and 0.21%（n=5） ,and the inter-day RSD were 1.73%,0. 67% and 0. 22%（n=5）. For adrenaline,the linear range was 1-100 μg/mL（r=0. 999 9）. At 10w,middle and high concentrations, the recovery rates were （ 102.89 ±0.85 ） %, （ 99.30 ± 0.43 ） % and （ 100.39 ±0.82） % （ n = 5 ）, the intra-day RSD were 0.94 %, 0.71% and 0.34 % （n = 5）, and the inter-day RSD were 1.37 %, 0.96 % and 0.55 % （n= 5）. Conclusion： The method is simple,accurate and suitable for the determination of articaine hydrochloride and adrenaline in compound articaine hydrochloride injection.
出处
《药学服务与研究》
CAS
CSCD
2007年第2期110-113,共4页
Pharmaceutical Care and Research
关键词
阿替卡因
肾上腺素
色谱法
高压液相
柱切换
articaine
eoinephrine
chromatography,hlgh pressure liquid
column-switching
