1.Determination of the Related Substances in Papaverine Hydrochloride Active Pharmaceutical Ingredients by HPLC
Ying LI ; Zhibo ZHENG ; Peng PENG ; Fuli ZHANG ; Liya LIN ; Jiangyuan HU ; Jianfen SHAO
Chinese Journal of Modern Applied Pharmacy 2024;41(13):1797-1802
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.
Result Analysis
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