Elemental impurities in Yataprasen Thai Polyherbal Formulation: source-dependent variation, and analytical method...

Area of Science:

• Analytical Chemistry
• Pharmacognosy
• Environmental Science

Background:

• Global consumption of complementary and alternative medicine (CAM) is increasing.
• Safety concerns exist regarding elemental impurities in herbal products.
• Yataprasen (YTPS), a Thai traditional polyherbal formulation, requires safety assessment for toxic metals.

Purpose of the Study:

• To optimize and validate an analytical method for quantifying toxic metals (As, Cd, Pb, Hg) in YTPS.
• To assess the toxicological risk of elemental impurities in YTPS from different sources.
• To identify the herbal contributors to elemental impurities in YTPS.

Main Methods:

• Inductively coupled plasma mass spectrometry (ICP-MS) was employed.
• Four acid-digestion protocols were evaluated for optimal sample preparation.
• Method validation included linearity, precision, recovery, LOD, and LOQ assessment.
• Toxicological risk assessment followed ICH Q3D(R2) guidelines.

Main Results:

• Digestion with 1 mL HNO3 yielded the highest accuracy and recovery.
• Validated method showed excellent accuracy (93.6-107.5% recovery) and linearity (R2 > 0.998).
• Naturally collected YTPS had significantly higher concentrations of As, Cd, Pb, and Hg compared to commercial YTPS.
• Allium sativum L., Cymbopogon nardus (L.) Rendle, and Melia azedarach L. were identified as major contributors to impurities.

Conclusions:

• Source-dependent variations in elemental impurities pose a greater toxicological concern for naturally collected YTPS.
• The validated ICP-MS method is a robust tool for quality control and regulatory assessment of polyherbal formulations.
• Standard addition is necessary for naturally sourced samples due to matrix effects, while external calibration suffices for commercial samples.