Two dimensional liquid chromatography system blood drug concentration monitoring equipment

Two dimensional liquid chromatography system blood drug concentration monitoring equipment

Brand: Innovative Universal

Model: GI-3000YT

Specification: all-in-one machine

1. ProductsPurpose:

Used clinically to analyze organic compounds derived from human blood samplesAnd inorganic ionic substancesQualitative and quantitative testing.Detectable drugs:Psychiatric drugsAntiepileptic drugs, hypnotic sedatives, anti-tumor drugs, antibiotics, anti tuberculosis drugs, monoamine drugs, analgesic drugs, circulatory system drugs, gastrointestinal drugs, and other inorganic ion drugs, etc

Two dimensional liquid chromatography system blood drug concentration monitoring equipmentIt is a two-dimensional liquid chromatography system built on top of a quaternary gradient liquid chromatography system, and is an online solid-phase extraction two-dimensional gradient liquid chromatography system with strong pre-processing capabilities. It is a combination of different separation mechanismsmutually independentA separation system consisting of two chromatography columns connected in series.Sample processingfrontThe one-dimensional chromatographic column enters the interface and is switched to the second dimensional chromatographic column and detector after concentration, capture, or cutting.systemUsually, two different separation mechanisms are used to analyze samples, namely, using the different characteristics of the sample to separate complex mixtures (such as peptides) into single components, including molecular size, isoelectric point, hydrophilicity, charge, special intermolecular interactions (affinity), etcfrontComponents that cannot be separated in a one-dimensional separation system may be better separated in a two-dimensional system, resulting in higher separation ability, resolution, or detection accuracydaThe improvement.

productThe system consists of five units: an automatic sampling system, a dual quaternary gradient high-pressure constant flow pump system, a two-dimensional comprehensive separation and analysis system, a UV detector, and functional chromatography software.

The schematic diagram of the system composition is as follows:

Sample pretreatment is used in HPLC analysisPart of it often requires manual and multi-step operations to complete, which takes more time than HPLC separation and data processing. Its function is to remove interfering substances from the sample, enrich trace components, facilitate detection and separation, and not damage the chromatographic column. Therefore, in the establishment of analytical methods and routine analysis, the precision and accuracy of the methods largely depend on the pre-treatment operations of the samples.

In recent years, with the rapid development of liquid chromatography technology, the automation level of HPLC has become increasingly high. In addition, the development of chromatographic column particle technology has greatly shortened the time for chromatographic separation. Undoubtedly, the automation of sample pre-processing technology will bring significant benefits to laboratory personnelThe benefits. Especially when faced with a large number of samples and cumbersome pre-processing processes, automation is the ideal choice, which is also in line with the development of HPLC technology. Solid phase extraction is a commonly used sample pretreatment technique, which is divided into online and offline methods for sample purification, impurity removal, and enrichment. Offline solid-phase extraction has advantages such as low reagent usage, time-saving, and easy SOP. Its disadvantage is that the SPE solid-phase extraction column can only be used once and has a high cost. Online solid-phase extraction (SPE) technology can automate processes such as activation, equilibration, impurity removal, and elution in a closed system, reducing errors caused by manual operations and improving the accuracy and precision of the method. Not only can it accelerate the sample pretreatment process, but the SPE column can also be reused, greatly reducing the overall analysis cost; More importantly, online SPE columns (3-10 μ m) have higher efficiency, better separation, cleaner samples, and are easier to separate by HPLC compared to offline SPE extraction columns.

twoProduct technical performance parameters

1. Core unit of constant flow pump，The high-pressure constant current pump technology using dual independent servo motors to drive ball screws has been sampled, which can improve system performance, reliability, stability, and durability.

2. Automatic sampling unit，Adopting automatic sampling computer full control technology with metering pump automatic extraction, high-pressure injection, mobile phase needle passing, and automatic cleaning of the inner and outer walls of the injection needle.

3. The stroke of the constant flow pump can be adjusted arbitrarily, allowing gradient mixing to be completed inside the pump. The equipment eliminates the independent gradient mixer, reducing the dead volume to a smaller degree and improving the repeatability index and detection speed of the equipment.

4. The detector adopts a high-speed data acquisition device with 24 bit AD conversion and signal sampling frequency of 80hz, ensuring low noise, low drift, ultra-high sensitivity, and improving the resolution and accuracy of the spectrum.

5. Upgradeable multiple detector technologies，Having international comparison*ofAmpere detector and Coulomb array detector technology products lay the foundation for the detection of various complex drug components，UV detector sampling frequency 80Hz.

6. Featuring a 10 inch 16:9 TFT high-resolution touch color screen(800 * 480 dot matrix control and computer software full reverse control for two functions.

7. Adopting a new type of photoelectric conversion and amplification circuit effectively reduces noise.

IIIMain functional features of the product

1. Fully automatic two-dimensional front-end processing function for non-uniform and complex test samples, such as blood samples, only requiring simple homogenization or no processing; Previously, samples required manual pre-processing, which was mostly done automatically by equipment.

2. The system has online enrichment function, and the detection sensitivity is much higher than that of conventional HPLC.

3. Replace the test sample without manual intervention to clean any consumables; All automatically completed.

4. The configuration and processing of the mobile phase can be automatically controlled by a computer.

5. The online processing capability of 1000 μ l ultra large samples (typical value of 500 μ l), the system automatically completes enrichment online, and the detection sensitivity is much higher than that of conventional HPLC by more than 5 times. The detection limit reaches ng level, ≤ 1 * 10-9G/mL (naphthalene)

6. Fully automated chromatographic quantitative analysis for complex samples

7. Equipped with an auxiliary high-pressure pump for online dilution function, it automatically completes large injection volume detection. No manual intervention is required to complete.

8detectionFast speed; The hardware system adopts 100MPa ultra-high pressure technology, and the software system adopts two-dimensional synchronous processing technology, reducing the time for a drug test to 5-10Minutes, greatly improving detection efficiency compared to before.

9. Equipped with a 10 inch 16:9 TFT high-resolution touch color screen (800 * 480 dot matrix) control and computer software reverse control functions

10. Special online two-dimensional transfer structureInterface technology，Online enrichment and temporary storage, with bothstrongThe ability to remove impurities,It also has good anti pollution ability and trace component detection,Even with a UV detector, excellent and pure chromatographic peaks can be obtained

11. The function of processing large quantities of samples can be controlled through computer programming, and automatic injection can be arranged in one go to complete the detection work automatically.

12. The chromatographic equilibrium time is usually less than 15 minutes and there is no need to clean the chromatographic column;

13Stable working curve maintenance time: 100 working days (typical value)

14Can be connected to various detectors such as mass spectrometry detectors, amperometry, coulombic electrochemical detectors, fluorescence detectors, etc

very strongThe 2D pre-processing function

1. Non uniformly complex samples, such as blood samples, only require simple homogenization or no processing;

2. Complex samples, such as lean meat, plant leaves, roots, and stem soaking solutions; Urine, cerebrospinal fluid, etc. require almost no treatment;

3. All analysis of small molecule substances does not require the use of organic solvents for extraction and does not emit polluting organic gases;

4Multiple sample testing, computer-controlled, automatic sample replacement for testing, automaticonlinepipeline cleaning,No need for manual intervention.

5. The mobile phase does not require filtration and can be directly configured in the mobile phase bottle;

6Auto-Control,Multi channel selection function, quick switching of analysis types, convenient for the determination of various small molecule substances.

Users can independently establish detection methods

1. It has multiple online processing modes to meet the diverse needs of complex samples with complex matrix components and simple matrix components;

2. Integrate multiple sample import systems for automated small molecule substance determination;

3. Capable of online dialysis, online processing, online analysis, and online data acquisition, meeting the in-depth needs of small molecule substance process analysis;

4. Can be used in conjunction with mainstream brand detectors, including optical detectors, electrochemical detectors, mass spectrometry detectors, etc., to complete various scientific research tasks;

5. Template measurement method guidance system, convenient for users to independently develop methods

fourMain functional and technical parameters of the system:

1. GI-3000-A01 automatic sampler:

(1) Using a syringe for quantitative analysis, the injection volume can be changed at any time through a computer without the need to replace the quantitative ring.

(2) Before and after injection, the outer wall of the injection needle can be high-pressure cleaned to reduce sample cross contamination

(3) Sample residue less than 0.005%

(4) Analytical type: 144 sample bottles

(5) Power supply 220V ± 10%, 50Hz200w

(6) Equipped with a 10 inch 16:9 TFT high-resolution touch color screen (800 * 480 dot matrix) control and computer software full reverse control functions

(7) Product size: 483 * 381 * 300 mm

2. GI-3000-P04 Four element ultra-high pressure gradient constant flow pump:

(1) Precision ball screw driven dual plunger reciprocating pump, with real-time pressure detection display, high pressure limit, low pressure limit alarm, and automatic flow rate compensation with system pressure changes.

(2) Flow range: 0.001-9.999ml/min; Set step size: 0.001mL/min

(3) Flow accuracy:<± 1%;

★ (4) Pump pressure: 45MPa

★ (5) Pressure pulsation: ≤± 0.02MPa

★ (6) Adopting a high-precision stepper motor to drive a precision ball screw system (Waters, 2695 scheme), minimizing failure points as much as possible, can greatly improve system performance and its reliability, stability, and durability in use.

★ (7) The device has removed buffers and gradient mixers, minimizing dead volume and greatly improving the device's repeatability and detection speed.

★ (8) The plunger stroke is adjustable and can be easily set and adjusted by a computer, making the flow more accurate.

(9) Flow accuracy correction

★ (10) It has two functions: a 10 inch 16:9 TFT high-resolution touch color screen (800 * 480 dot matrix) control and computer software reverse control

★ (11) The pressure of the pump can be displayed up to 0.01 MPa, allowing for further observation and mastery of subtle changes in pressure fluctuations.

3. GI-3000-D01 UV detector:

(1) Wavelength range: 190nm-700nm;

(2) Spectral bandwidth: 5nm;

(3) Wavelength indication error: ≤± 1nm;

(4) Baseline noise: ≤± 1 × 10-5 AU (methanol, 1ml/min, 254nm, 20 ℃);

(5) Baseline drift: ≤± 3 × 10-4 AU/h (methanol, 1ml/min, 254nm, 20 ℃);

(6) Detection concentration: ≤ 2 × 10-9g/ml (naphthalene);

(7) Wavelength scanning: multi wavelength time programming (10 bands);

(8) Pool volume: 8 μ L;

(9) System repeatability RSD6 (qualitative): ≤ 0.05%

(10) System repeatability RSD6 (quantitative): ≤ 0.2%

(11) Equipped with computer software anti control function

(12) Adopting a new H-shaped circulation pool with bi-directional convection to ensure minimal fluctuations in the baseline

4Two position liquid chromatography system

(1) Temperature control range: 5 ℃ to 80 ℃ (room temperature<25 ℃);

(2) Temperature control accuracy: ≤± 0.1 ℃;

★ (3) Comprehensive separation and analysis system, which can be set and controlled by chromatographic data processing workstation, and can be controlled by computer for automatic analysis switching;

(4) The temperature inside the system box can be controlled in both cooling and heating directions

(5) Temperature setting resolution: 0.1 ℃

(6) Equipped with computer software anti control function

5. Auxiliary pump

(1) Equipped with online dilution function of high-pressure auxiliary pump

(2) Auxiliary constant current pump withstand pressure 45MPa

6. GI3000 Workstation:

(1) Equipped with a two-dimensional liquid chromatography system on-screen guidance operation interface.

(2) The software can perform full reverse control operation control, automatic data acquisition, spectrum processing, etc. on the system; We used a liquid chromatography control and data sampling system software with independent intellectual property rights (software copyright registration number: 2012SR024750). It can better meet the specific requirements of users based on their actual situation.

(3) The software includes permission management and audit tracking functions, meeting the requirements of national GMP certification and the pharmaceutical industry.

(4) The method files used can provide long-term storage and unified management of analytical parameters, spectral data, and analysis reports of the chromatograph;

(5) Full Chinese operation menu, intuitive and convenient user-friendly interface;

(6) The workstation has the ability to compare spectra in multiple forms, which is beneficial for chromatographic research;

(7) Control method: Equipped with computer reverse control function, in compliance with GLP requirements

(8) Working method: Implement data collection, calculation, organization, storage, and printing on the front and back desk

fiveBasic configuration:

1. GI-3000-P04 Four element Ultra high Pressure Gradient Constant Flow Pump System

Two sets of (built-in four element proportional valve, online deaerator, including online plunger rod cleaning device),

2. Two sets of GI-3000-G04 four unit online deaerator (built-in),

3. A set of GI-3000-D01 UV detector system,

4. A set of GI-3000-T01 comprehensive separation and analysis system,

5. One set of GI-3000-A01 automatic sampler system,

6. A set of GI-3000 chromatography control software system,

7. One secondary analysis column

8. First levelSPEOne pillar

9. One set of high-pressure dilution pump

six、productPurpose:

1）Used in clinical practice for qualitative or quantitative detection of inorganic or organic compounds derived from human blood samples.

2) Scope of detectable drugs: psychiatric drugs, antiepileptic drugs, hypnotic sedatives, anti-tumor drugs, antibiotics, anti tuberculosis drugs, monoamines, analgesic drugs, circulatory system drugs, gastrointestinal drugs, or other drugs.

7、 After sales service:

The product comes with a three-year warranty, free software upgrades, and lifetime service provided by the manufacturer.

Explanation of professional terms:

ISO 13485 is a quality management system certification standard for the medical device industry. It is based on ISO 9001 and focuses more on the safety and effectiveness of medical devices, clarifying the design and production processes

The quality control requirements from production to after-sales are aimed at ensuring that medical devices comply with regulations and user needs, and are widely recognized and adopted in the field of medical devices.