S. Joseph
2009
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Journal
The Indian pharmacist
Abstract
Out of eight specific impurities of Atenolol (as per EP), one of them, i.e. Impurity-D, is a potential genotoxic impurity. Thus, sensitivity of the purity indicating method becomes critical for the quantification of this impurity. This study describes an ultraviolet (UV) and mass spectrometry (MS) detector chromatographic method for quantification of Atenolol impurities. The method developed was simple and short run-time, with clearly better resolution and more sensitive than the existing European Pharmacopoeia (EP) and United States Pharmacopeia (USP) methods. Agilent's Mass Hunter Optimization (MHO) software was used for quick optimization of MS parameters. Using Agilent's 1200 series rapid resolution liquid chromatography (RRLC) with UV detection, potential impurity was quantified in the range of 2.00-0.03% with a linearity coefficient greater than 0.9999 (limit percentage ≤ 0.25%). Connecting the Agilent's 6410B triple quadrupole (TQ) mass spectrometry detector to Agilent's 1200 RRLC, quantification range was effectively reduced further down to 5ppb (parts per billion) with linearity coefficient greater than 0.9992. The limit of detection (LOD) for MS/MS method was 3ppb. The observed multiple reaction monitoring (MRM) transition for impurity-D was m/z 244.1-107.