This Application Note evaluates the performance of the Agilent 1290 Infinity LC system for the determination of impurities and related substances of metoclopramide hydrochloride in a pharmaceutical formulation. The translation of a conventional liquid chromatography (LC) method on a 1200 Series HPLC system to an ultra high pressure method on an Agilent 1290 Infinity LC system is discussed. Method translation is relatively easy and temperature fine-tuning is the most important parameter to obtain the same selectivity for the different impurities. Pressures as high as 1070 bar were applied during method development. The final high productivity method is carried out at 880 bar in an analysis time of 3.5 min which is approximately 4 times faster than the original HPLC method but with the same accuracy. A validation study was carried out to demonstrate the performance of the Agilent 1290 Infinity LC system. Limits of detection for the impurities were as low as 0.001 % w/w relative to the main compound using the new diode array detector (DAD). This is more than one order of magnitude lower than required.
This document evaluates the performance of the Agilent 1290 Infinity LC system for determining impurities and related substances in metoclopramide hydrochloride formulations. It details the translation of a conventional liquid chromatography (LC) method from a 1200 Series HPLC system to an ultra-high pressure method on the 1290 Infinity LC system. The study highlights that method translation is relatively easy, with temperature fine-tuning being the most important parameter to maintain selectivity for different impurities.
The final high productivity method achieves an analysis time of 3.5 minutes, which is approximately four times faster than the original HPLC method, while maintaining the same accuracy. The system utilized a high-pressure pump capable of delivering up to 1200 bar and a new fast and sensitive diode array detector (DAD), achieving limits of detection for impurities as low as 0.001% w/w relative to the main compound.
| Maximum pressure | 1200 bar |
|---|---|
| Analysis time | 3.5 min |
| Detection limit | 0.001 % w/w |
| Column particle size | 1.7-µm |
| Detector type | Diode Array Detector (DAD) |
The final high productivity method is approximately 4 times faster than the original HPLC method.
Temperature fine-tuning is the most important parameter to obtain the same selectivity for the different impurities.
Pressures as high as 1070 bar were applied during method development.