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Determination of Ephedrine HCl and Pseudoephedrine HCl in Xiao’er Kechuanling Oral Solution with Purospher® STAR RP-18e column

Dean Duan

MilliporeSigma China Application Lab Shanghai, China

Chinese Pharmacopeia Method

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

This application focuses on the determination of ephedrine HCl and pseudoephedrine HCl. Oral solution samples were distilled to extract the ephedrine HCl and pseudoephedrine HCl. Samples were then filtered through Millex® PTFE syringe filters, prior to HPLC-UV analysis using a Purospher® STAR RP-18 endcapped HPLC column.

The limit of detection (LOD) and the limit of quantitation (LOQ) were 0.04 µg/kg and 0.12 µg/kg, respectively, for ephedrine, and 0.02 µg/kg and 0.06 µg/kg, respectively, for pseudoephedrine. 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.

Materials
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Determination of Ephedrine HCl and Pseudoephedrine HCl in Xiao’er Kechuanling Oral Solution

Purospher® STAR RP-18e

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 standard 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 in 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

Specificity: Inject reference solution and determine the retention time of desired analyte in presence of other components like impurities.

Table 3.Specificity data of ephedrine and pseudoephedrine HCl.
Table 4.Standard repeatability data of ephedrine HCl.
Table 5.Standard repeatability data of pseudoephedrine HCl.

Calibration Data - Ephedrine

Linearity (area mAU*min), ephedrine HCl

Table 6.Linear range of ephedrine HCl.

LOD and LOQ, ephedrine HCl

Table 7.LOD and LOQ of ephedrine HCl.
Calibration curve of ephedrine HCl used to measure the analyte in Xiao’er Kechuanling oral solution using Purospher® STAR RP-18e colμmn

Figure 5.Calibration curve of ephedrine HCl.

Calibration Data - Pseudoephedrin

Linearity (area mAU*min), pseudoephedrine HCl

Table 8.Linear range of pseudoephedrine HCl.

4.2 LOD and LOQ - pseudoephedrine HCl

Table 9.LOD and LOQ of pseudoephedrin HCl.
Calibration curve of pseudoephedrine HCl to measure the analyte in Xiao’er Kechuanling oral solution using Purospher® STAR RP-18e colμmn

Figure 6.Calibration curve 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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