HPLC determination of the content and related substances in irinotecan hydrochloride injection

Objective: To establish a method for determination of the content and related substances in irinotecan hydrochloride injections.Methods: HPLC was performed on a Suplex PKB-100 column with the mobile phase of phosphate buffer(Potassium dihydrogen phosphate 1.36 g and Octanesulfonic acid sodium 2.18 g,dissolved in water 1000 mL,and the pH adjusted to 3.5 using phosphoric acid)-methanol-acetonitrile(55∶ 25∶ 20)at a flow rate of 1.0mL·min-1;the column temperature was 30 ℃,and the detection wavelength was 254 nm.Results: The liner range of calibration curve for irinotecan hydrochloride was 0.0255-0.1788 mg·mL-1(r=0.9999),the RSD of precision was 0.04%(n =5),and the RSD of repeatability was 0.40%(n =6),the average recovery was 100.2%(RSD=0.9%,n =9);the sample solution has a good stability in 8 h,the limit of quantitation was 0.91 ng,the limit of detection was 0.27 ng.The repeatability and recovery of the known impurities were good.Conclusion: The established method is suitable for determination of the content and related substances in irinotecan hydrochloride injections.