Study on the Preservative and Solvent Residues of Maiwei Dihuang Oral Liquid
Objective To establish a method for the detection and evaluation of preservatives (benzoic acid and sorbic acid) and solvent residues (methanol and ethanol) in maiwei dihuang oral liquid,and to provide technical support for the quality safety evaluation of maiwei dihuang oral liquid. Methods Determination of residual methanol and ethanol using a capillary column (30 m × 0.32 mm×1.8 μm) with 6% (V/V) cyanopropyl phenyl-94% (V/V) dimethylpolysiloxane (DB-624) as fixed liquid;with a programmed temperature increase;the inlet temperature was 200 ℃;the FID detector temperature was 250 ℃;the carrier gas flow rate was 2.0 mL/min;and the split ratio was 20∶1. The detection of benzoic acid and sorbic acid was performed using an Agilent Eclipse XDB-C18 column (250 mm × 4.6 mm,5 μm);the mobile phase was a mixture of acetonitrile and 0.1% phosphoric acid;the flow rate was 1.0 mL/min;the detection wavelengths for benzoic acid and sorbic acid were 230 nm and 260 nm,respectively;and the column temperature was 30 ℃ . Results The established method has good linearity,specificity,stability,and reproducibility.The results of the detection of 15 batches of maiwei dihuang oral liquid produced by 6 enterprises showed that 3 batches of one enterprise had excessive ethanol residues. Conclusion The established method is accurate and specific,and this method can be used for the quality safety evaluation of maiwei dihuang oral liquid.