Determination of the Related Substances in Papaverine Hydrochloride Active Pharmaceutical Ingredients by HPLC
10.13748/j.cnki.issn1007-7693.20230961
- VernacularTitle:HPLC 测定盐酸罂粟碱原料药中的有关物质
- Author:
Ying LI
1
;
Zhibo ZHENG
2
;
Peng PENG
2
;
Fuli ZHANG
3
;
Liya LIN
3
;
Jiangyuan HU
4
;
Jianfen SHAO
4
Author Information
1. School of Pharmacy, Fudan University, Shanghai 201203, China
2. Collaborative Innovation Center of Yangtze River Delta Region Green Pharmaceuticals, Zhejiang University of Technology, Hangzhou 310014, China
3. Shanghai Research Institute of Pharmaceutical Industry Co., Ltd., Shanghai 201213, China
4. Zhejiang Boxian Biopharmaceutical Co., Ltd., Hangzhou 311400, China
- Publication Type:Journal Article
- Keywords:
papaverine hydrochloride ； HPLC ； related substance
- From:
Chinese Journal of Modern Applied Pharmacy
2024;41(13):1797-1802
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE :To establish an HPLC method for determination of the related substances in papaverine hydrochloride.
METHODS
NanoChrom ChromCore 120 C8 column was used; the mobile phase A consisted of 3.4 g·L−1 potassium dihydrogen phosphate aqueous solution, adjust pH to 3.5 with phosphoric acid-acetonitrile(90∶10), the mobile phase B was methanol, with gradient elution at the flow rate of 0.8 mL·min−1; the detection wavelength was 238 nm; the column temperature was 50 ℃.
RESULTS
The minimum separation between the main component and each impurity was >1.5; Papaverine and its thirteen impurities showed a good linear relationship in the self-concentration range(r>0.999); and the average recoveries were 93.1%−101.2% with RSDs of 2.3%−8.1%.
CONCLUSION
The method is accurate, sensitive and reliable, which is suitable for the determination of related substances in papaverine hydrochloride.
