Optimize the Compatibility Condition of Vidarabine Monophosphate for lnjection by Orthogonal Test

OBJECTIVE To investigate multiple factors on the compatibility stability of Vidarabine Monophosphate for Injection mixed with different solvents. METHODS L₁₈(3⁵) of orthogonal design was used with five factors: temperature, illumination, storage time, solvent and amount of solvent. With the content of vidarabine monophosphate, pH value changes of the compatibility solution and the insoluble particles as indexes, the content of vidarabine monophosphate in the mixture was determined by HPLC, the change of pH value before and after compatibility determined by pHs-2C type precision acidity meter, the insoluble particles were observed by GWJ-4 type particle analyzer. RESULTS There were no significant changes in appearance and character of the mixture in the inspection time. The temperature and time showed significant effects on the contents of vidarabine monophosphate in the mixture, and illumination could influence the number of insoluble particles. The solvent and amount of solvent had no significant influence on all indexes. CONCLUSION The optimal compatibility conditions as follows: temperature of 25 ℃, under the incandescent lights, compatibility time of 4 h, and 100 mL 0.9% sodium chloride injections as the solvent.