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2023

Application Guide—PuriFlash® 5.250 + iELSD Enables High-Throughput Purification of Active Pharmaceutical Ingredients!

Purification is a critical step in drug development. From analytical studies to scale-up and process optimization, purification and characterization are essential steps in bringing a drug to market.

Application Guide—PuriFlash® 5.250 + iELSD Enables High-Throughput Purification of Active Pharmaceutical Ingredients!

2023-11-07

Purification is a critical step in drug development. From analytical studies to scale-up and process optimization, purification and characterization are essential steps in bringing a drug to market. Therefore, it is imperative to have a high-throughput solution that can provide sufficient quantities of purified compounds. And... Advion Interchim Scientific Preparative chromatography systems can easily achieve separation of active pharmaceutical ingredients. (API) To separate it from impurities and achieve the purpose of purification.

Case Sharing

Use AIS puriFlash ^®5.250 Preparation system for over-the-counter drugs (OTC) The five active ingredients were purified, including caffeine, glafenine, ketoprofen, flavonoids, and fenofibrate (Figure). 1 ), while using expression ^® CMS Small desktop mass spectrometer simultaneously confirms compounds. ID 。

1. Caffeine: Caffeine is a naturally occurring chemical substance with stimulating effects, found in coffee, tea, cocoa, and other foods.

2. Grafenin: Grafinin is a nonsteroidal anti-inflammatory drug. (NSAID) Due to the high risk of allergic reactions, 1991 Withdraw from the market this year.

3. Ketoprofen: A nonsteroidal anti-inflammatory drug (NSAID) Ketoprofen is used to treat inflammation, swelling, stiffness, and joint pain. Due to an increased risk of heart attack, stroke, irritation, and other problems, this medication has been... 1995 Ceased production this year.

4. Flavonoid: A metabolite commonly found in plants.

5. Fenofibrate: A prescription medication used to lower and treat high levels of cholesterol and triglycerides (lipid substances) in the blood.

Experimental Procedure

LC Analysis conditions

Mobile phase A ： Water + 0.1% TFA

Mobile phase B ： Acetonitrile

Chromatographic column: Aquity UPLC BEH C18 1.7 mu m, 50x2.1mm ID

Flow rate: 1mL/min

Sample loading method: Liquid sample loading

Sample volume: 1 mu L

Detection wavelength: UV254nm

Elution conditions

T( min)	A(%)	B(%)
00:00	95	5
01:40	2	98

LC Separation results

Preparation conditions

System: PuriFlash ^® 5.250 + iELSD

Mobile phase A ： Water

Mobile phase B ： Acetonitrile

Chromatographic column: US5C18HQ-150/300

Flow rate: 32mL/min

Sample loading method: Liquid sample loading

Sample volume: 0.5mL

Rough sample: 50mg

Elution conditions

T( min)	A(%)	B(%)
00:00	95	5
10:00 PM	0	100

Experimental results

The following figure shows, respectively, UV Scan ( Green )， ELSD (35 ° C) ( Blue )， TIC 160-500 m/z ， XIC 371-374 m/z ， XIC 220-224 m/z ( Purple ) The data graph shows that the five substances were well separated and confirmed by mass spectrometry.

Conclusion

1. Advion Interchim Scientific expression ^® CMS A small desktop mass spectrometer can identify the isolated compounds quickly and accurately, enabling the rapid and precise detection of compounds of interest.

2. Advion Interchim Scientific Adopt an integrated approach iELSD With PuriFlash ^® 5.250 The purification and preparation system is integrated. , can be realized Sample with no UV absorption The detection.

Keywords:

Application Guide—Coupling Thin-Layer Chromatography with Mass Spectrometry and Flash Chromatography for Intelligent and Rapid Purification

What kind of sparks will fly when intelligent software meets purification and preparation?