Résumé
Objective To study optimal compatibility scheme of vidarabine monophosphate for injection combined with aciclovir injection. Methods L18(35) of orthogonal design was used with five factors: temperature, illumination,storage time,solvent and solvent dosage;the insoluble particles were observed by GWJ-4 type particle analyzer.The content of vidarabine monophosphate and aciclovir was detected by HPLC.Optimization of the best scheme of vidarabine monophosphate for Injection combined with aciclovir injection was studied.Results The regression equation of vidarabine monophosphate and aciclovir were A=3.78 ×104C+2.32, r=0.9997(n=5)and A=7.11 ×105C-4.65, r=0.9995(n=5),The results showed that the relationship between the range of 200-900μg/mL(vidarabine monophosphate) and the range of 1000-4500μg/mL(aciclovir) was good.The optimal compatibility conditions are the follows:temperature of 25,as far as possible away from light;Vidarabine monophosphate for injection 1 (0.1 g/branch) and 1 acyclovir injection (10 mL:0.5 g) mixed with 100 mL 0.9% sodium chloride injection,and dropping out within 4 h after compatibility. Conclusion The optimal compatibility scheme has good repeatability,injection solution stability is good.It prouides scientific reference for the safty of clinical rational drug use.
Résumé
Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.