RP-HPLC法同时测定盐酸阿普林定片的含量和有关物质  

Content Determination of Aprindine Hydrochloride Tablets and Its Related Substances by RP-HPLC

作　　者：王昕[1] 唐素芳[1] 王卫[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药房》2015年第6期842-845,共4页China Pharmacy

摘　　要：目的：建立同时测定盐酸阿普林定片含量及有关物质的方法。方法：采用反相高效液相色谱法。色谱柱为Dikma Diamonsil C18,流动相为甲醇-水-10%四丁基氢氧化铵溶液（40∶60∶2,V/V/V,用磷酸调节p H至3.0）,流速为1.0 ml/min,检测波长为258 nm,柱温为30℃,进样量为10μl。结果：盐酸阿普林定质量浓度在25.55～204.40μg/ml范围内与其峰面积呈良好的线性关系（r=0.999 4）;精密度、稳定性、重复性试验的RSD≤0.6%;平均回收率为100.1%,RSD=0.5%（n=9）;杂质总量≤0.84%。结论：本方法简便、准确、专属性好、灵敏度高,可用于盐酸阿普林定片的质量控制。OBJECTIVE： To develop the method for the content determination of Aprindine hydrochloride tablets and its related substances. METHODS： RP-HPLC method was adopted. The determination was performed on Dikma Diamonsil C18 column with mobile phase consisted of methanol-water-10% tetrabutyl ammonium hydroxide （40：60：2.0, V/V/V, adjusted to 3.0 using phosphor- ic acid） at the flow rate of 1.0 ml/min. The detection wavelength was set at 258 nm, and column temperature was 30 ℃. Sample size was 10 μl. RESULTS： The linear range of aprindine hydrochloride were 25.55-204.40 μg/ml （r=0.999 4） ; RSDs of preci- sion, stability and reproducibility tests were lower than 0.6%; the average recovery was 100.1% （RSD=0.5% ,n=9）;the total amount of impurities was lower than 0.84%. CONCLUSIONS： The method is simple, accurate, specific and sensitive, and can be used for quality control ofAprindine hydrochloride tablets.

关 键 词：盐酸阿普林定片 含量测定 有关物质 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]