Development of a Quantitative Chromatographic Fingerprint Analysis Method for Sugar Components of Yuanhu Zhitong Oral Liquid Using HPLC-CAD

OBJECTIVE To establish a quantitative fingerprint analysis method for sugar components in Yuanhu Zhitong oral liquid using high performance liquid chromatography-charged aerosol detection(HPLC-CAD).

METHODS Chromatographic column was NH₂P-50 4E(4.6 mm×250 mm, 5 μm) column. Water(A) and acetonitrile(B) were used as the mobile phase in the gradient elute mode. The column temperature was 30 ℃. The injection volume was 10 μL. The flow rate was 0.6 mL·min⁻¹. The evaporation temperature of CAD was 35 ℃. The acquisition frequency was 10 Hz. The power function value was 1.0.

RESULTS The linear relationship of the quantitative component was good within the quantitative range, with R²>0.999. The relative standard deviations(RSDs) of instrument precision, intermediate precision and method repeatability were all <3%. The test solution was stable within 24 h. The average recoveries at low, medium and high concentration levels ranged 97.15%−101.13%. There were 5 common peaks in the fingerprint. The RSDs of instrument precision, method repeatability and sample stability were all <4%.

CONCLUSION The established analytical method is stable, accurate and reproducible. It can be used to detect sugar excipients in the preparations.