Determination of the Related Substances in Papaverine Hydrochloride Active Pharmaceutical Ingredients by HPLC

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.