Development of a Validated UV Spectrophotometric Method for the Estimation of Ambrisentan in Pure and Marketed Formulations
Journal Title: Scholars Academic Journal of Pharmacy - Year 2014, Vol 3, Issue 6
Abstract
A simple, accurate, rapid and sensitive UV spectrophotometric method has been developed for the estimation of Ambrisentan (ABS) in bulk as well as in marketed formulations. Ambrisentan is used in the treatment of pulmonary hypertension. It is available in the market in tablet dosage forms with strength 5mg and 10mg. The present research work involves the estimation of Ambrisentan using 0.1 N NaOH as a solvent. An absorption maximum (λ max) was found to be 263.5 nm. It obeys the Beer’s law in the concentration range of 10-50µg/ml with a correlation coefficient value of 0.9993. The %RSD was found to be below 2.0 for repeatability, Intra and Inter-day precision indicated that the method was highly precise. The LOD and LOQ were found to be 0.522 & 1.944 μg/ml revealed that the method was sensitive. The percentage recoveries were found to be 98.62 - 100.05 %, indicating the accuracy of the method and absence of interference of the excipients present in the formulation. Validation of the method has been carried out statistically as per ICH guidelines and the results were found to be satisfactory. The proposed method was simple, fast, specific, accurate, precise, rugged and reproducible and hence can be applied for routine quality control analysis of Ambrisentan in pharmaceutical formulations. Keywords: Ambrisentan, Spectrophotometric method, tablet dosage forms, Validation, ICH guidelines
Authors and Affiliations
Mohammad Yunoos, N. S. L. Lavanya ,, G. Sravani ,, P. Madhuri Rao, Ch. Krishna ,
Keywords
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