Rapid ultra-performance liquid chromatography assay of losartan potassium in bulk and formulations

Abstract

Background: Losartan potassium is a non-peptide AT1 receptor drug used in the treatment of hypertension. Methods: A simple, rapid, sensitive, and validated isocratic reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed and validated for the determination of losartan potassium (LOS) in bulk drug and tablets. The assay was developed using Waters Acquity BEH C18 (100 mm × 2.1 mm), 1.7-μm column with a mobile phase consisting of a mixture of phosphate buffer (pH 3.2) and acetonitrile (50:50 v/v). Results: An assay with a total run time of only 5 min was developed. The method monitored at 245 nm exhibited linearity over a concentration range of 2.0 to 15.0 μg mL−1 LOS. The limits of detection and quantification (signal-to-noise ratio (S/N) = 10) were found be 0.018 and 0.054 μg mL−1, respectively. The intraday and interday RSDs were less than 1.0%. The method was validated by the determination of LOS levels in tablets where the percentage on the label claim was 100 ± 2. The accuracy of the method was further ascertained by recovery studies via the standard addition procedure, which yielded satisfactory results. Conclusion: A rapid UPLC assay of LOS in bulk drug and tablets was developed and validated.