Affiliation:
1. Alexandria University, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, Alexandria 21521, Egypt
2. Suez Canal University, Faculty of Pharmacy, Department of Pharmaceutical Analytical Chemistry, Ismaillia 41552, Egypt
3. Auburn University, Harrison School of Pharmacy, Department of Drug Discovery and Development, Auburn, AL 36849
Abstract
Abstract
A novel, simple, direct, and selective stability-indicating GC/MS procedure was developed for the determination of the anti-ischemic drug trimetazidine dihydrochloride (TMZ) in the presence of two of its related substances (potential impurities), namely, 2,3,4-trimethoxybenzyl alcohol (T1) and 2,3,4-trimethoxybenzaldehyde (T2). The method involved resolution of the underivatized compounds using a 100% dimethylpolysiloxane (Rtx-1) capillary column, and MS detection was carried out in the electron-impact mode. The peaks of the three compounds eluted at retention times 11.69, 11.92, and 15.47 min for T1, T2, and TMZ, respectively. Quantification of the parent drug TMZ was based on measuring its peak area. The reliability and analytical performance of the proposed method, including linearity, range, precision, accuracy, selectivity, detection, and quantification limits, were statistically validated. The calibration curve of TMZ was linear over the range 100–600 μg/mL. The proposed method was successfully applied to the assay of TMZ in several commercially available pharmaceutical formulations with recoveries not less than 96.2%.
Publisher
Oxford University Press (OUP)
Subject
Pharmacology,Agronomy and Crop Science,Environmental Chemistry,Food Science,Analytical Chemistry
Cited by
10 articles.
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