The pH range is wide (1.5-12.0);
Two polar tail seals have strong separation ability for polar compounds;
Special bonding, with super strong stereoisomer recognition ability;
Hydrophilic and compatible with 100% water mobile phase.
Tianjin Bonaijer Technology is proud to launch the Durashell C18-AM chromatography column based on the new generation of silicone gel and bonding technology. Firstly, it uses inert treatment technology to prepare silica gel, which can maintain stability in alkaline mobile phase and significantly improve its lifespan compared to traditional silica gel; Secondly, it has strong stereoisomerism recognition ability, suitable for the separation of structurally similar compounds, especially for the simultaneous analysis of multiple impurities in drugs.
Performance indicators of chromatographic column:
Note *: For better lifespan and performance, it is recommended to use the Durashell series within the most suitable pH range of 2.0-10.0
Durashell C18-AM has good batch reproducibility and lifespan
In the cefradine injection test, the use of high concentrations of ion pair reagents and buffers (total concentration 54 mM) and high pH (8.0) resulted in many chromatographic columns having short lifetimes, while Durashell C18-AM exhibited excellent durability.
Content determination and related substance inspection of cefradine for injection
Durashell C18-AM chromatogram for determination of cefradine content for injection
Content determination and testing method:
Mobile phase:Wash with a solution of disodium hydrogen phosphate containing 0.027 mol/L sodium octanesulfonate (pH adjusted to 8.0 with phosphoric acid) - methanol (75:25) at an equimolar ratio;
Detection wavelength:206 nm；Column temperature:30℃；Injection volume:10 μL；Current Speed:1.0 mL/min；
Chromatographic column:Durashell C18-AM, 5 μ m, 100 Å, 4.6 × 250 mm.
Regarding substance determination
Durashell C18-AM is used for the determination of sample solutions of cefradine related substances for injection
Regarding substance detection methods:
Mobile phase:Water: methanol: 3.86% sodium acetate solution -4% acetic acid solution (1564:400:30:6), isocratic elution;
Detection wavelength:254 nm；Column temperature:30 ℃；Injection volume:20 μL；Current Speed:1.0 mL/min；
Chromatographic column:Durashell C18-AM, 5 μ m, 100 Å, 4.6 × 250 mm.
Related substance results of cefradine injection sample:
1. The retention time of cefradine for injection is 6.7 minutes, the column efficiency is 9501, the tailing factor is 0.939, and the separation between the cefradine peak, cefradine peak, and arginine peak meets the requirements of the Chinese Pharmacopoeia;
Good batch reproducibility
Long service life
Using the method of content detection, samples with added arginine were continuously injected, and the chromatographic column was cleaned every 80 injections. The retention time, column efficiency, and peak shape of cefradine were observed, as well as the separation of arginine from unknown impurity 4. If no significant changes were observed, the next test was conducted. This cycle resulted in a total of 280 injections.
Continuous injection of 280 injections resulted in no significant changes in retention time, column efficiency, tailing factor, etc.
In the testing of cefradine for injection, the use of high concentrations of ion pair reagents and buffer solutions (total concentration 54 mM) and high pH (8.0) resulted in the retention of the main peak, decreased column efficiency, and decreased impurity separation in many chromatography columns within 50 injections in the first test. Durashell C18-AM exhibits excellent durability, with stable retention, good separation, and high column efficiency even after 1100 injections.
EP Pharmacopoeia Risperidone Related Substance Testing
Impurities A B、C、D、 Risperidone, Impurity E
Chromatographic column:Durashell C18-AM； 5 μm，100 Å； 4.6×100 mm；
Mobile phase A:Weigh 5.0 g of ammonium acetate, dissolve in 1000 mL of water, and filter through a 0.45 μ m membrane.
Mobile phase B:Methanol;Current Speed:1.5 mL/min；Wavelength:260 nm；
Column temperature:30℃；Injection volume:10 μL；
Gradient:
Separation of degradation products of USP lansoprazole
Durashell C18-AM chromatographic column HPLC chromatogram of related substances in the degradation products of lansoprazole raw materials
Chromatographic column:Durashell C18-AM； 5 μm，100 Å； 4.6×250 mm；
Wavelength:285 nm；Column temperature:30℃；
Current Speed:1.5 mL/min； Injection volume: 40 μ L;
Mobile phase A: Water
Mobile phase B: Acetonitrile: Water: Triethylamine (160:40:1), pH 7.0 adjusted with phosphoric acid
Gradient:
Detection and Separation of Azithromycin
Azithromycin is a macrolide antibiotic, and in the 2015 edition of the Chinese Pharmacopoeia, analysis is required for all eight possible impurities it may contain. At present, there are very few chromatographic column varieties on the market that can meet the analysis of azithromycin, and the chromatographic columns that can barely be used also have the problem of unstable separation.
Durashell C18-AM Plus undergoes strict production processes and quality control to ensure batch stability. Each chromatographic column is tested with actual azithromycin drug samples before leaving the factory to ensure that every product received by customers achieves good performance. It is a specialized chromatographic column tailored for azithromycin analysis.
Test 1: [Related Substances]
Figure 1. Standard diagram for systematic suitability testing of substances in the Chinese Pharmacopoeia in 2015
Figure 2. Applicability test results of related substance system for Durashell C18-AM Plus special column for azithromycin in Bonajar
Liquid phase conditions:
Chromatographic column: 5 μ m, 4.6 × 250 mm;
Mobile phase A: Buffer solution (take 0.05mol/L dipotassium dihydrogen phosphate solution, adjust pH to 8.2 with 20% phosphoric acid solution): Acetonitrile=40:60
Mobile phase B: Methanol
Wavelength: 210 nm;
Flow rate: 1 mL/min
Column temperature: 30 ℃;
Injection volume: 50 μ L;
Gradient condition:
Explanation: When analyzing azithromycin and its related substances using Durashell C18-AM Plus, the composition of mobile phase A was adjusted, and a buffer solution of acetonitrile=40:60 was used to achieve good separation of azithromycin within the specified retention time of 30-40 min. The separation degree of the most difficult impurities I and J reached 1.9, greatly exceeding the required 1.2.
Test 2: [Content Determination]
Liquid phase conditions:
Chromatographic column: 5 μ m, 4.6 × 250 mm;
Wavelength: 210 nm;
Flow rate: 1 mL/min;
Column temperature: 30 ℃;
Injection volume: 50 μ L;
Mobile phase: Phosphate buffer solution (take 0.05 mol/L dipotassium hydrogen phosphate solution, adjust pH to 8.2 with 20% phosphoric acid solution): Acetonitrile=45:55
Conclusion:
According to the method required by the Pharmacopoeia of the People's Republic of China Part II (2015 edition) and optimized, azithromycin was analyzed and tested. The separation degree of each impurity in the relevant substance system adaptability test was greater than the required 1.2 (as shown in Table 1), and the retention time of the azithromycin peak was between 30-40 minutes (as shown in Figure 2), meeting the detection requirements in the Pharmacopoeia.