Original Articles
Ivanka Pencheva, Lily Peikova,
Abstract
The aim of this study is developing and validation of two analytical methods (UV-spectrophotometric and HPLC) for determination of Metoprolol tartrate and Hydrochlorothiazide fixed-dosage combinations. The investigation includes validation of procedures for performance of the tests for identification, purity and assay. Analytical parameters precision, accuracy, selectivity, linearity, limit of detection and limit of quantitation were studied and compared. The both methods allow simultaneously determination of Metoprolol tartrate and Hydrochlorothiazide at different conditions (algorithm, wavelength zones, column and mobile phase). The preferences of each of them were estimated on the comparison of analytical parameters from the validation procedures. They let to compose the criteria in accordance with European Pharmacopoeia and EU regulates about the use of official analytical programms for quality control of fixed-dosage drugs. The methods has been applied successfully in analysis of pharmaceutical preparation in the appointed for each of them aspect of applications.