气相色谱法测定长链脂肪乳注射液的脂肪酸组成OA

A gas chromatography analysis system for fatty acid compositions of long chain fat emulsion injection was established to provide a refer-ence for evaluating the quality consistency between the test formulation and the reference formulation.A DB-WAX(30 m×ϕ0.32 mm,0.25 μm)strong polarity gas chromatographic column was employed with an injection volume of 1 μL and a split ratio of 50∶1.The initial column temperature was 230℃(holding for 11min),ramped up to 250℃at a rate of 5℃/min,and maintained for 10 min,with the inlet temperature of 260℃,and the detector temperature of 270℃.In this experiment,a method was established successfully to determine 11 fatty acids compositions of long chain fat emulsion injection.The validated results indicated that the method exhibited well-suited specificity,linear and range,precision,solution stabili-ty and robustness,and the RSD fulfilled the requirements.The fatty acid compositions of six batches for the analysis were checked successfully.