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Preparation of Aztreonam Impurity

Application Introduction

Aztreonam has s weak immunogenicity and a low cross allergy probability with penicillins and cephalosporins, thus it can be used for substituting aminoglycosides to treating aerobic gram-negative bacteria infection of patients with renal impairment;

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Introduction

Aztreonam has s weak immunogenicity and a low cross allergy probability with penicillins and cephalosporins, thus it can be used for substituting aminoglycosides to treating aerobic gram-negative bacteria infection of patients with renal impairment; under the close observation, it also can be used for treating the patients allergic to penicillins and cephalosporins. The aztreonam impurity shall be added with buffer salt during analysis. During the medium-pressure preparation, buffer salt is replaced with TFA (concentration: 0.1%) to simplify the posttreatment process.

Table 1 Aztreonam Impurity Sample Information

Structural   formula

Molecular   formula

Molecular   weight

C13H19N5O6S

373.38

Experimental

Instrument, reagents and materials

Cheetah® MP 200 purification system

Deionized water; chromatographic solvent methanol;

Preparative chromatographic columns: Flash AQ C18, (20-35 µm, 100 Å, 12 g, three columns connected in series)

Sample pretreatment

The sample is yellow powder solid. Add 1 mL of methanol to 5 mg of the sample, and ultrasonically dissolve the mixed matter. Filter the sample with a 0.22 µm membrane, and then perform the sample loading.

Preparation conditions

Chromatographic columns: Flash AQ C18 (20-35 µm, 100 Å, 12 g, three columns connected in series)

Mobile phases: A: TFA aqueous solution (concentration: 0.1 %), B: methanol

Flow rate: 12 mL/min

Wavelength: 220 nm (blue rays), 254 nm (red rays)

Gradient:

Table 2 Gradient Elution Conditions of Liquid Preparation Chromatography

Time/min

Flow rate/(mL/min)

A/%

B/%

0.0

12.0

100.0

0.0

30.0

12.0

70.0

30.0

Detection conditions

Chromatographic columns: Innoval ODS-2 (10 µm, 100 Å, 4.6 × 250 mm)

Mobile phases: A: TFA aqueous solution (concentration: 0.1 %), B: methanol

Flow rate: 1.0 mL/min

Detector: UV (wavelength: 254 nm)

Column temperature: 30 °C

Gradient:

Table 3 Gradient Elution Conditions of Liquid Analysis Chromatography

Time/min

Flow rate/(mL/min)

A/%

B/%

0.0

1.0

100.0

0.0

30.0

1.0

70.0

30.0

Results and Discussion

In this experiment, aztreonam impurity sample is prepared with Flash AQ C18 (20-35 µm, 100 Å, 12 g, three columns connected in series) packing. As shown in Table 2 and Figure 1, the sample passes the preparation test and shows a good peak shape after going through the gradient elution in the mobile phases including TFA aqueous solution (concentration: 0.1%) and methanol.

Figure 1 Preparation Chromatogram

Figure 2 Detection Chromatogram of Pre-preparation Sample

Figure 3 Detection Chromatogram of Preparative Receiving Liquid

 

Conclusion

Results show that Flash AQ C18 (20-35 µm, 100 Å, 12 g, three columns connected in series) packing has a good effect on the aztreonam impurity sample in reservation and separation.

 


  • 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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