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Determination of Related Substances of Gemcitabine Hydrochloride by HPLC and Study on Its Stability

??OBJECTIVE To establish an HPLC method to determine the related substances of gemcitabine hydrochloride for quality control and observe the stability of gemcitabine hydrochloride. METHODS An HPLC method was used to detect the related substances in gemcitabine hydrochloride. The stability of gemcitabine hydrochloride under various degradation conditions and the stability of its solution at room temperature were studied.RESULTS Impurity Z2 was the main substance detected under each degradation conditions, the amount of Z2 increased proportionally with time at room temperature, and the increased amount exceeded the upper limit of quality standard by 20%(0.02%) at 24 h. CONCLUSION Impurity Z2 markly increases under some degradation conditions and at room temperature, indicating that gemcitabine hydrochloride solution is unstable. The HPLC method has good specificity and linearity, which is suitable for quality control of gemcitabine hydrochloride and its pharmaceutical preparations.