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 t0 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.
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