目的 建立琥珀酸索利那新原料藥中有關(guān)物質(zhì)的HPLC測定方法。方法 建立了高效液相色譜（HPLC）法，Agilent ZORBAX SB-Phenyl色譜柱（250 mm×4.6 mm，5μm），以磷酸鹽緩沖液-甲醇-乙腈（70：20：10）為流動相A，以磷酸鹽緩沖液-甲醇-乙腈（30：30：40）為流動相B，進行梯度洗脫；檢測波長為220 nm；柱溫35℃；體積流量為1.5 mL/min；進樣體積20 μL。采用加校正因子自身對照法計算琥珀酸索利那新原料藥中雜質(zhì)1~5。結(jié)果 琥珀酸索利那新中雜質(zhì)1~5的相對保留時間分別為0.34、0.39、1.2、1.7、2.3，校正因子分別為1.3、0.86、0.49、0.94、0.47。各雜質(zhì)定量限相當(dāng)于主成分濃度的0.005%~0.007%。雜質(zhì)回收率在93.0%~94.4%。結(jié)論 該方法的專屬性、線性、靈敏度、準(zhǔn)確度、重復(fù)性、溶液穩(wěn)定性均符合要求，可用于琥珀酸索利那新原料藥中有關(guān)物質(zhì)測定。

Objective To establish an HPLC method for the determination of related substances in solifenacin succinate active pharmaceutical ingredient. Methods The determination was carried out on ZORBAX SB-Phenyl chromatographic column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of phosphate buffers-methanol-acetonitrile (70:20:10) (A) and Phosphate buffers-methanol-acetonitrile (30:30:40) (B) with gradient elution. The detection wavelengths were set at 220 nm. The flow rate was 1.5 mL/min, temperature of column was set at 35℃, and volume of injection was 20 μL. The self-contract method of principle component using the correction factor method was used to calculate the content of the related substances 1-5. Results The relative retention time of impurities 1-5were 0.34, 0.39, 1.2, 1.7, and 2.3, respectively, and the correction factors were1.3, 0.86, 0.49, 0.94, and 0.47, respectively. Limits of detection (LOD) of impurities were in the range of 0.005%-0.007%. The recoveries were 93.0%-94.4% for all impurities. Conclusion The specificity, linearity, sensitivity, accuracy, repeatability, and solution stability of the method meet the requirements, and can be used for the determination of the related substances in solifenacin succinate active pharmaceutical ingredient.