Abstract

To establish a comprehensive quality control method for Qili Qiangxin Capsules, an HPLC-DAD-ESI-MS/MS approach was developed for characteristic chromatogram analysis, marker compound identification, and multi-compound quantification. Similarity analysis of the characteristic chromatogram was conducted, and 25 characteristic peaks were identified using MS/MS fragment information. Methodological validation (specificity, linearity, precision, stability, repeatability, spiked recovery) was performed, followed by content determination of the 25 marker compounds. Results showed that the similarity of 10 batches of samples was >0.9 (Peak 6 as reference peak). The methodological validation for the quantitative analysis of 25 compounds met the requirements. All 25 compounds exhibited good linearity (R2 > 0.999), with spiked recoveries of 98–103% (RSD < 2.0%). All validation indicators met Chinese Pharmacopoeia requirements. The established method is specific, precise, and stable, enabling simultaneous characteristic chromatogram identification and multi-compound quantification of Qili Qiangxin Capsules. It provides technical support for production quality supervision and clinical medication safety, and offers a reference for quality control of similar traditional Chinese medicine preparations.

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