Development of a HPLC-DAD method combined with multicomponent chemometrics and antioxidant capacity to monitor the quality consistency of compound bismuth aluminate tablets by comprehensive quantified fingerprint method

摘要

A high performance liquid chromatography (HPLC) coupled with diode array detector method was developed to monitor the quality consistency of a classical compound preparation, compound bismuth aluminate tablet. Characteristic fingerprints of 30 batches of samples were methodically generated by HPLC, and the validation results have demonstrated that the optimized HPLC method had achieved the desired precision, repeatability and stability. The five-wavelength fusion fingerprint profiles were constructed by integrating the chromatograms at five different wavelengths. A novel and optimized method, which was defined as comprehensive quantified fingerprint method, was used to evaluate the quality consistency of samples. The contents of seven major components were determined and subsequently analyzed by principal component analysis, of which the correlation was explored by orthogonal projection to latent structures method. Furthermore, the antioxidant activities were determined by an off-line antioxidant activity to explore the relationship with fingerprint evaluations. In summary, a synthetic evaluation strategy was established in terms of five-wavelength fusion fingerprints evaluations, multiple component chemometrics analyses, antioxidant activity assay, and a comprehensive quantified fingerprint method was developed to monitor the quality consistency for the preparation of traditional Chinese medicine compounds.