ABSTRACT

A new, accurate, precise, and durable RP-HPLC method with sensitive features has been developed for the simultaneous assessment of Telmisartan (TEL) and Azelnidipine (AZEL) in both bulk and tablet format. An Agilent C18 column with a size of 100 mm × 4.6 mm, 5 ?m was used to estimate the solutes. TEL and AZEL were eluted in a 10-minute gradient trial at a flow rate of 0.7 ml/min with an ambient column temperature of 25°C and monitored at a wavelength of 257 nm using orthophosphoric acid (0.05%) buffer: acetonitrile in a 70:30 v/v ratio. The retention times of TEL and AZEL were found to be 3.587 minutes and 5.633 minutes, respectively. The Q2A and Q2B validations of the analytical method demonstrated good linearity throughout the concentration ranges of 20-100 ?g/mL for TEL and 4-20 ?g/mL for AZEL, with r2 of 0.999 in both cases. High accuracy, excellent precision (inter-day and intra- day), and remarkable resilience values were also shown by the technique. The suggested analytical method proved precise, accurate, and robust for frequent analysis of the drug combination in bulk and tablet forms. Keywords: Telmisartan, Azelnidipine, RP-HPLC, Simultaneous, Estimation, Validation
Publication date: 01/05/2023

https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7127.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.5.7127