7 Critical Components You Must Qualify and Control in HPLC for Accurate Results

In today’s video, we dive into the seven essential components that must be qualified in High-Performance Liquid Chromatography (HPLC) systems to ensure compliance with EDQM guidelines. These qualifications are critical for achieving accurate, precise, and reliable results in pharmaceutical analysis. Below is a summary of each component, its role, and the key experimental methods involved in the qualification process.
0:13 Solvent Delivery System
The solvent delivery system is responsible for delivering the mobile phase at a precise flow rate and pressure. Proper qualification ensures consistent chromatographic performance.
Qualification Methods:
Flow Rate Accuracy and Precision
Gradient Composition Accuracy
Gradient Ripple
1:49 Injector
The injector ensures that sample volumes are consistently introduced into the system, directly impacting the accuracy of the analysis.
Qualification Methods:
Volume Precision
Carry-over Test
Injection Linearity and Accuracy
3:25 Autosampler
The autosampler automates sample introduction and maintains temperature control for sensitive samples.
Qualification Methods:
Thermostating Accuracy
Thermostating Stability
4:22 Oven/Cooling Device (Column Thermostat)
This device maintains the column at a constant temperature to ensure reproducible retention times and peak shapes.
Qualification Methods:
Thermostating Accuracy
Thermostating Stability
5:10 Multiwavelength Detector
A UV/Vis or other multiwavelength detector monitors the analytes passing through the column. Qualification ensures accurate concentration measurements.
Qualification Methods:
Linearity
Wavelength Accuracy
Drift Test
6:44 Fluorescence Detector
For methods requiring fluorescence detection, this component must be qualified to ensure the correct detection of excitation and emission wavelengths.
Qualification Methods:
Wavelength Accuracy (Excitation and Emission)
Signal-to-Noise Ratio
7:48 System Suitability Tests
Ongoing system suitability tests confirm that the system remains in optimal condition during routine analysis.
Qualification Methods:
Peak Area Precision
Retention Time Precision
Carry-over Test
Signal-to-Noise Ratio
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[@Pharmainform]

Good

[@pharmatalks6885]

@@Pharmainform Thanks for your attention 💯🙏

[@GMPforAll]

thanks for sharing

[@pharmatalks6885]

Thanks for watching!