Spectrophotometric Determination of Losartan Potassium in Tablets

Abstract

In the quality control of pharmaceutical products, it is of utmost importance that validated analytical methods are used to ensure the credibility of the results generated. At the time of the study, official monographs from the United States Pharmacopeia and National Formulary (USP-NF) for the quantification of Losartan potassium in tablets were unavailable, denoting the need for a validated analytical procedure for the analysis of the drug. The study adapted direct and first-derivative UV spectrophotometry methods proposed by Bonfilio and others (2010) for the assay of Losartan potassium in Losartan 50 mg. capsules, then modified and validated the said procedures for the assay of Losartan potassium in Losartan 100 mg. tablets following the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on method validation for accuracy, precision, specificity, linearity, limit of detection, and limit of quantitation. Results demonstrated that all the performance characteristics of both methods were highly satisfactory and confirmed the possible application of the methods in routine analysis of Losartan potassium tablets.

Keywords

• Losartan Potassium
• UV spectrophotometric determination
• assay validation
• direct and first-derivative spectra
• hypertension