Comparison of two methods for the determination of sucrose octasulfate concentration in irinotecan hydrochloride liposomes
10.16438/j.0513-4870.2019-0638
- VernacularTitle:两种测定盐酸伊立替康脂质体注射液中蔗糖八硫酸酯定量法的比较
- Author:
Hui-jia WANG
1
;
Yuan-jian WANG
1
,
2
;
Chen LIANG
3
;
Qian CAI
4
;
Hong-sheng XU
5
;
Qing LI
1
Author Information
1. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China
2. Bostal Drug Delivery Co., Ltd., Guangzhou 510530, China
3. Bostal Drug Delivery Co., Ltd., Guangzhou 510530, China
4. Liaoyuan Food and Drug Administration, Liaoyuan 136200, China
5. Zhejiang Shapuaisi Pharmaceutical Co., Ltd., Jiaxing 314200, China
- Publication Type:Research Article
- Keywords:
HPIC-CD;
HPLC-RID;
sucrose octasulfate;
irinotecan hydrochloride;
liposome
- From:
Acta Pharmaceutica Sinica
2020;55(3):501-505
- CountryChina
- Language:Chinese
-
Abstract:
HPLC-RID and HPIC-CD methods were established for the determination of sucrose octasulfate content in irinotecan hydrochloride liposomes for injection. HPLC-RID: This method was performed on a Kromasil 100-5-NH2 column (250 mm×4.6 mm, 5 μm) with a mobile phase of 0.8 mol·L-1 ammonium sulfate buffer (pH 3.5)-acetonitrile (83∶17). The flow rate, column temperature and detector temperature were maintained at 1 mL·min-1, 30 ℃ and 30 ℃ respectively. HPIC-CD: This method was performed on an anion exchange column Dionex InPacTM AS11-HC (250 mm×4 mm, 9 μm) with an eluent of 30 mmol·L-1 sodium hydroxide solution. The flow rate was 1.5 mL·min-1, the column temperature was 30 ℃ and the detector temperature was 35 ℃. The HPLC-RID method and HPIC-CD method were validated with respects to specificity, limit of detection, limit of quantitation, linearity, precision, accuracy, stability and robustness and met the validation requirements. There were no significant differences between the HPIC-CD and HPLC-RID methods according to T-test analysis, both of which were applicable for the measurement of sucrose octasulfate concentration in irinotecan hydrochloride liposomes for injection. However, the HPLC-CD was better at the following aspects: higher detection sensitivity, simpler sample pretreatment, lower time and money spent, better environmental protection.
