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HomeSmall Molecule HPLCDetermination of Ephedrine HCl and Pseudoephedrine HCl in Xiao’er Kechuanling Oral Solution using a Discovery® HS C18 Column

Determination of Ephedrine HCl and Pseudoephedrine HCl in Xiao’er Kechuanling Oral Solution using a Discovery® HS C18 Column

Dean DuanMerck

China application lab Shanghai, China

Ephedrine hydrochloride and pseudoephedrine hydrochloride are the active ingredients in the Chinese traditional medicine Xiao’er Kechuanling oral solution, which can be used to reduce cold, allergic rhinitis, rhinitis and sinusitis caused by nasal congestion symptoms and control bronchial asthma.

This application focuses on the determination of ephedrine HCl and pseudoephedrine HCl. Oral solution samples were distilled to extract ephedrine HCl and pseudoephedrine HCl. Samples were then filtered through Millex® PTFE syringe filters, prior to HPLC-UV analysis using a Discovery® HS C18 column.

The limit of detection (LOD) and the limit of quantitation (LOQ) were 0.002 µg/ mL and 0.006 µg/ mL, respectively, for ephedrine HCl, while it was 0.02 µg/mL and 0.07 µg/ mL, respectively, for pseudoephedrine HCl. The method can be used for determination of ephedrine HCl and pseudoephedrine HCl in Xiao’er Kechuanling oral solution.

2-D chemical structures (bond line structure) of ephedrine HCl and pseudoephedrine HCl compounds used to determine analytes in Xiao’er Kechuanling oral solution.

Figure 1.Chemical structures of compounds used in the study.

Determination of ephedrine HCl and pseudoephedrine HCl in Xiao’er Kechuanling oral solution

Table 1.HPLC conditions.
Separation of ephedrine HCl and pseudoephedrine HCl standards used to determine analytes in Xiao’er Kechuanling oral solution by HPLC-UV method.

Figure 2.Chromatogram of ephedrine HCl and pseudoephedrine HCl standard solution.

Chromatogram showing peaks of Xiao’er Kechuanling oral solution used to determine analytes in Xiao’er Kechuanling oral solution by HPLC-UV method.

Figure 3.Chromatogram of Xiao’er Kechuanling oral solution.

Chromatographic run of solvent blank in HPLC-UV separation of ephedrine HCl and pseudoephedrine HCl standards used to determine analytes in Xiao’er Kechuanling oral solution.

Figure 4.Chromatogram of solvent blank.

Table 2.Specificity data of ephedrine HCl and pseudoephedrine HCl.

Specificity and repeatability – ephedrine and pseudoephedrine

Table 3.Specificity data of ephedrine and pseudoephedrine.
Table 4.Standard repeatability data of ephedrine.
Table 5.Standard repeatability (3 µg/mL), pseudoephedrine HCl.
Table 6.Linear range of ephedrine HCl.
Calibration curve of ephedrine HCl to measure the analyte in Xiao’er Kechuanling oral solution using Discovery® HS C18 column.

Figure 5.Calibration curve of ephedrine HCl.

Table 7.LOD and LOQ of ephedrine HCl.

Calibration data – pseudoephedrine HCl

Table 8.Linear range of pseudoephedrine HCl.
Calibration curve of pseudoephedrine HCl to measure the analyte in Xiao’er Kechuanling oral solution using Discovery® HS C18 column.

Figure 6.Calibration curve of pseudoephedrine HCl.

Table 9.LOD and LOQ of pseudoephedrine HCl.

Conclusion

The method can be used for ephedrine HCl and pseudoephedrine HCl in Xiao’er Kechuanling oral solution.

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