Abstract
A direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection-18 AA by ion-pair reversed-phase high-performance liquid chromatography with ultraviolet detection is described. The separation of both impurities in Compound Amino Acid Injection-18 AA was accomplished with gradient elution consisting of acetonitrile and 10 mM diammonium hydrogen phosphate buffer (containing 15 mM sodium 1-heptanesulfonate and obtaining pH 2.3 by addition of phosphoric acid). The limits of detection (μg/mL, S/N = 3:1) and quantification (μg/mL, S/N = 10:1) of methionine sulfoxide and pyroglutamic acid were 0.02 and 0.08, and 0.06 and 0.19, respectively. The linearity was in the range of 0.08–200.20 μg/mL for methionine sulfoxide and 0.19–201.20 μg/mL for pyroglutamic acid. The relatively simple method proved accurate (recovery 99.68–102.98% for methionine sulfoxide, 98.10–102.00% for pyroglutamic acid, n = 9) and precise (repeatability RSD = 1.06% for methionine sulfoxide, RSD = 0.60% for pyroglutamic acid, n = 6) in its application to commercial Compound Amino Acid Injection-18 AA.
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