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 l.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.
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