阿昔洛韦有关物质检查中的鸟嘌呤对照品溶液配制方法的改进  

Improved preparation method of guanine reference substance solution in Acyclovir related compounds testing

作　　者：倪叩 王智 王文晞 NI Kou;WANG Zhi;WANG Wen-xi(Hubei institute for Drug control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院,武汉430075 [2]武汉中生毓晋生物医药有限责任公司,武汉430270

出　　处：《中国处方药》2023年第1期36-38,共3页Journal of China Prescription Drug

摘　　要：目的改进鸟嘌呤对照品溶液的配制方法,解决其在弱碱性环境下不稳定的问题。方法以资生堂MG C_(18)(4.6 mm×250 mm,5μm)为固定相,甲醇-水(10∶90)为流动相,流速1.0 ml/min,柱温35℃,检测波长254 nm。结果鸟嘌呤对照品溶液p H值为3.0时,鸟嘌呤在1.32~2.46 mg/L之间有良好的线性关系(相关系数为0.9998),对照品主峰面积进样精密度良好(RSD=0.12%),对照品溶液在48 h内稳定。结论该配制方法提高了鸟嘌呤对照品溶液的稳定性,提升了方法耐用性,可广泛用于阿昔洛韦制剂中鸟嘌呤检查项鸟嘌呤对照品的制备。Objective To improve the preparation method of guanine reference substance solution,in order to avoid the instability of alkalescencent guanine solution.Methods Using a column packed with Octadecyl silane bonded silica gel as the fixed phase[Shisei hubei do MG C_(18)(4.6 mm×250 mm,5μm)]and a mixture of Methanol-water(10∶90)as the mobile phase at a flow rate of 1.0 ml/min,Column temperature:35℃,detection wavelength is 254 nm.Results When the pH value of guanine reference solution is 3.0,there is a good linear relationship between 1.32~2.46 mg/L of guanine(correlation coefficient is 0.9998),the precision of the main peak area of the reference solution is good(RSD=0.12%),and the reference solution is stable within 48 hours.Conclusion This preparation method improves the stability of guanine reference solution,improves the durability of the method,and can be widely used for the preparation of guanine reference in acyclovir preparations.

关 键 词：鸟嘌呤 阿昔洛韦 高效液相色谱法 PH值 

分 类 号：R927.2[医药卫生—药学]