Abstract
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.
Highlights
Losartan potassium is a non-peptide AT1 receptor drug used in the treatment of hypertension
The aim of this study is to develop and validate, according to the current ICH guidelines, a fast, accurate, precise, and sensitive ultra-performance liquid chromatography (UPLC) method for the analysis of losartan potassium (LOS) in tablets without the interference from inactive ingredients
Water-acetonitrile mixture, and methanol were evaluated to obtain suitable composition of the mobile phase. Parameters such as the retention time, peak shape, theoretical plates, and run time were the major tasks while developing the method
Summary
Losartan potassium is a non-peptide AT1 receptor drug used in the treatment of hypertension. A monopotassium salt of 2-butyl-4chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl] imidazole5-methanol or (2-butyl-4-chloro-1-{[2′-(1H-tetrazol-5-yl) biphenyl-4-yl]methyl}-1H-imidazol-5-yl)methanol (Figure 1), is a non-peptide AT1 receptor antagonist used for the treatment of hypertension (Conlin 2001). Losartan potassium was the first angiotensin II receptor antagonist to be marketed. It is marketed by Merck and Co. Inc. Several analytical techniques have been reported for the determination of losartan potassium (LOS) in different pharmaceutical formulations and in biological fluids. Most of these methods employ highperformance liquid chromatography (HPLC) with UV detection (Seburg et al 2006; Pedroso et al 2009). The drug LOS is determined by HPLC in the presence of other drugs
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