Evaluating Formulation-Dependent Chemical Variation and Comparability of Maziren-Wan Preparations via Multi-Component LC-MS/MS Profiling.

Background/Objectives: Maziren-Wan (MZRW) is a traditional herbal prescription that has been used for the treatment of chronic constipation and is currently available in the form of granules or decoctions. Given its multi-component nature and various dosage forms, evaluating the chemical consistency of MZRW preparations is important for pharmaceutical quality assessment. The aim of the present study was to compare formulation-dependent chemical profiles of different MZRW preparations using a multi-component analytical approach. Methods: An excipient-free reference extract and two commercially available MZRW extract granule products were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method operating in multiple reaction monitoring mode. Thirty marker compounds derived from the constituent herbs were simultaneously quantified, and their levels were statistically compared among the preparations. Results: Quantitative analysis revealed formulation-dependent variation in the abundance of several marker compounds. Amygdalin and magnoloside A exhibited markedly higher levels in the excipient-free reference extract than in the commercial granule products, whereas sennoside A showed relatively consistent levels across the preparations. Conclusions: The results indicate that MZRW preparations sharing an identical herbal composition can exhibit formulation-dependent differences in chemical profiles. Comparative evaluation based on multiple marker compounds may provide useful information for assessing chemical consistency and supporting quality assessment of MZRW preparations formulated under different conditions.