The United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) permit a degree of adjustment of HPLC parameters such as column size, mobile phase condition etc. if it is satisfying the requirements of system suitability. Allowable adjustment parameters are described in General Chapter <621> Chromatography of USP 41 and General Chapter 2.2.46 Chromatographic separation techniques of EP 9 each. Although both Pharmacopoeias permit to modify parameters, the allowable adjustments range may be different. For example, it is possible to modify the column size under the gradient condition in EP, but not allowed in USP. Modifying these analytical parameters within range is expected to reduce the analysis time.
This Technical Note introduces an example of analysis of Levocetirizine Dihydrochloride Tablets -ORGANIC IMPURITIES- in accordance with the USP. And an example of analysis that can be completed in a shorter analysis time after modifying the condition which is based on the USP General Chapter <621> Chromatography.