Development, Validation, and Concentration Determination of Losartan Potassium Using 1D UV Visible Spectrophotometry

Abstract

Maneesha C Abeysekera35048, Muditha B Herath35049, Shehani H Basnagoda35050 and Udaya K Jayasundara35051*

Losartan Potassium (LP) is a non-peptide antihypertensive agent that manifests its effect by specifically blocking angiotensin II receptors which are used to treat hypertension. This research was carried out to develop and validate a simple and accurate Ultraviolet- Visible (UV-Vis) spectrometric method to determine the Active Pharmaceutical Ingredient (API) content in commercially available LP formulations stored at room temperature and refrigerator conditions. All the parameters were validated following the International Conference on Harmonization (ICH) guidelines. An intense peak at 234 nm was observed for the first derivative 1D UV spectrum of LP and it was taken for the quantitative evaluation. Accuracy was tested with the spiked recovery method and the percentage recovery was observed in the range of 90% to 110%. Precision was evaluated utilizing intra-day and inter-day precisions giving a percent Relative Standard Deviation (%RSD) ≤ 2 for each concentration. Linearity was found in the range of 5-15 ppm with a correlation coefficient (R2) of 0.994. Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found to be 0.489 ppm and 1.511 ppm, respectively. Stability testing revealed that standard and test solutions are stable up to 14 days under room temperature and refrigerator conditions and met the acceptance criteria of ± 10% deviation from the initial value. Market sample analysis was carried out using the percentage recovery method. All the samples met the acceptance criteria suggested by the ICH. Hence, the developed method was found to be a simple, sensitive, and economical procedure that does not employ any harmful reagents.