LC-MS approach
for the contaminant’s quantification in anti-retroviral API
Baluni Subodhkumar and Bastikar Virupaksha
Res. J. Biotech.; Vol. 20(10); 188-198;
doi: https://doi.org/10.25303/2010rjbt1880198; (2025)
Abstract
The current work focuses on procedure development for analysis and then further
authentication for quantifying contaminant G (4-Dimethylaminopyridine) and contaminant
S (N-[(Phenylmethoxy)carbonyl]-L-valine 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)
methoxy]ethyl ester) in Valaciclovir Hydrochloride Hydrate anti-retroviral active
pharmaceutical ingredient (API) powder using Liquid Chromatography-Mass Spectrometry
(LC-MS) tactic. This newly settled LC-MS procedure of analysis is proposed to complement
the existing method (Thin layer chromatography) for quantifying contaminant G and
contaminant S in the Valaciclovir Hydrochloride Hydrate API monograph.
The LC-MS method with Ascentis Express C18 (2.7μm, 4.6 mm X 15cm) analytical HPLC
column was hired to fix the levels of Contaminant G and Contaminant S in Q1 Multiple
ion mode. A gradient system consisting of cyanomethane (Reservoir B) and formic
acid ammonium ion salt (0.01M), pH 3.0 (Reservoir A) was used for the elution of
analytes, with separate compositions. The method developed was authenticated in
agreement with the strategies mentioned in International Conference on Harmonization.
Contaminant G quantitation limit was found to be 204.16ppm whereas contaminant S
limit was found to be 215.60 ppm respectively.
