Quality consistency evaluation of commercial transfer factor injections by chromatographic fingerprint combined with multivariate statistical analysis

Abstract

The current quality control methods relying mainly on chromogenic reaction can hardly ensure the quality and safety of the biochemical drug with complex chemical composition. Therefore, a chromatographic fingerprint method was developed for the quality evaluation of a multicomponent biochemical drug, transfer factor injection. High-performance liquid chromatography fingerprint was measured by using a C 18 column (250 × 4.6 mm, 5 µm) with a mobile phase composed of 0.1% trifluoroacetic acid-water and 0.085% trifluoroacetic acid-acetonitrile under gradient elution. The developed method was validated and was subsequently applied to 57 batches of commercial products which were sampled by National Drug Assessment Program.High-resolution mass spectrometry analysis was performed on characteristic peaks of fingerprints, and a series of amino acids, nucleosides, and deoxynucleosides were identified. In the fingerprint assessments, principal component analysis and Hotelling T 2 analysis yielded the best results. The results generally indicated that there was a significant difference among products of batch-to-batch or from different manufacturers. Abnormal samples and its discriminatory components were also explored. In summary, the established fingerprinting method with multivariate statistical analysis could offer an efficient, reliable, and practical approach for quality consistency evaluation of transfer factor injection, providing a reference for the quality control of other multicomponent biochemical drugs. K E Y W O R D Shigh-performance liquid chromatography fingerprinting, multivariate statistical analysis, multicomponent biochemical drugs, transfer factor injection, quality consistency evaluation 2042

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