Update: 29 September, 2023
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.
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MD5 Checksum: 905F9BF285867F6D8765C3DBAC8AF2E7
Publication date: 02 July, 2012
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