莫西沙星氯化钠注射液溶液颜色控制方法研究

Study on color control of moxifloxacin sodium chloride injection solution

目的 对盐酸莫西沙星氯化钠注射液的溶液颜色与质量关系进行研究,筛选科学、准确的溶液颜色控制方法。方法 采用多种方法(目视比色法、紫外-可见分光光度法、色差计法)对盐酸莫西沙星氯化钠注射液的溶液颜色进行对比,研究溶液颜色与杂质含量的相关性,探索科学准确的溶液颜色的质控方法。结果 盐酸莫西沙星氯化钠注射液的溶液颜色越深,光降解杂质含量越高,杂质含量与溶液颜色呈正相关性;色差计法可准确直观的反映溶液颜色变化的趋势,具有较强的区分力。结论 色差计法准确、直观、区分力强,可作为本品溶液颜色测定的方法,同时结合有关物质对本品中的有色杂质进行监测。

Objective To study the relationship between the solution color and the quality of moxifloxacin hydrochloride sodium chloride injection, a scientific and accurate color control method was selected.Methods A variety of methods(visual colorimetry, UV-Vis spectrophotometry and color difference meter)were adopted to compare the solution color of moxifloxacin hydrochloride sodium chloride injection, to study the correlation between the solution color and impurity content, and to explore a kind of scientific and accurate solution color quality method. Results The darker the solution color of moxifloxacin hydrochloride sodium chloride injection, the higher the content of photodegradation impurity, and the impurity content was positively correlated with the solution color. The color difference meter method could accurately and intuitively reflect the trend of solution color change and had strong distinguishing force. Conclusions The color difference meter method is accurate, intuitive and can be used as a method to determine the solution color of the product, and at the same time, can be combined with related substances to monitor the colored impurities in the product.