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Purification of Propoxy Aildenafil in Anti-fatigue Health Care Products

Application Introduction

In certain kidney-reinforcing health care products, propoxy aildenafil derived from sildenafil is illegally added.

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Introduction

In certain kidney-reinforcing health care products, propoxy aildenafil derived from sildenafil is illegally added. Since there are many types of sildenafil derivatives and there is no clear standard about propoxy aildenafil at present, propoxy aildenafil is purified by the preparation method based on high-pressure preparative liquid in this experiment for research on its nature and hazards.

Table 1 Propoxy Aildenafil

Sample name

English name

Structural formula

Molecular formula

Molecular weight

Propoxy   aildenafil

Propoxy   aildenafil

C24H34N6O4S

502.64

Experimental

Instrument, reagents and materials

Cheetah® HP 100;

Deionized water; TFA; chromatographic solvent: acetonitrile;

High-pressure preparative columns: Innoval ODS-2 (10 µm, 100 Å, 50 × 250mm)

Sample pretreatment

Take certain health care wine as the sample. Evaporate 40 mL of the wine sample by rotation to concentrate it to 13 mL at ambient temperature, add ethanol to dilute the sample to 100 mL, and then filter the sample with a 0.22µm membrane.

Preparation conditions

Chromatographic columns: Innoval ODS-2 (10 µm, 100 Å, 50 × 250 mm);

Mobile phases: A: TFA aqueous solution (concentration: 0.05%), B: acetonitrile;

Detector: 230 nm, 254nm

Flow rate: 80 mL/min

Sample size: 20 mL

Gradient:

Table 2 Gradient Elution Conditions of Liquid Chromatography

Time/min

Flow rate/(mL/min)

A/%

B/%

0.0

80.0

90.0

10.0

20.4

80.0

35.8

64.2

21.1

80.0

0.0

100.0

28.7

80.0

0.0

100.0

Detection conditions

Chromatographic columns: Innoval ODS-2 (5 µm, 100 Å, 4.6 × 250 mm);

Mobile phases: A: TFA aqueous solution (concentration: 0.05%), B: acetonitrile;

Detector: 230 nm

Flow rate: 1.0 mL/min

Sample size: 5 µL

Column temperature: 35 °C

Gradient:

Table 3 Gradient Elution Conditions of Liquid Chromatography

Time/min

Flow   rate/(mL/min)

A/%

B/%

0.0

1.0

90.0

10.0

30.0

1.0

10.0

90.0

Results and Discussion

In this experiment, propoxy aildenafil is prepared with Innoval ODS-2 (10 µm, 100 Å, 50 × 250 mm) packing. As shown in Table 2 and Figure 1, the sample prepared shows a good peak shape after going through the gradient elution in the mobile phases including TFA aqueous solution (concentration: 0.05%) and acetonitrile. Besides, the purity of the product prepared is conforming to the requirement of customer.

Figure 1 Preparation Chromatogram

Figure 2 Detection Chromatogram of Fraction at 18min

Table 4 Integral results

Integral resu

NO.

Name

Reservation time

Peak area

Area percent

Peak width

Peak type



Min


%

Min


1

N.A.

16.113

0.294

0.638

0.169

BB

2

N.A.

16.708

0.100

0.217

0.133

BB

3

N.A.

17.514

0.126

0.273

0.104

BB

4

N.A.

17.933

0.081

0.175

0.014

BB

5

N.A.

18.143

45.565

98.697

0.179

BB

Total



46.167

100.000

0.120


 

Figure 3 Empty Detection Chromatogram

 

Conclusion

In this experiment, propoxy aildenafil is prepared with Innoval ODS-2 (10 µm, 100 Å, 50 × 250 mm) chromatographic columns. Results show that Innoval ODS-2 (10 µm, 100 Å, 50 × 250 mm) packing is able to separate this sample with a good effect.

 


  • Innoval ODS-2

    Innoval ODS-2 has excellent mechanical strength, which could be used under pressure up to 6000psi. Its low surface area, provide fast separation speed, also more tolerance ability for dirty sample. Innoval ODS-2 could provide good separation ability for hydrophilic compounds, compatible with 100% aqueous mobile phase.

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