For the analysis of amlodipine besylate and valsartan in drug substance as a fixed dosage form, a
simple, valid, exact, and contemporaneous UV spectrophotometric approach was devised. The
quantitative measurement of mixed dosage of amlodipine besylate is 3-Ethyl 5-methyl2-[(2-
aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydro-3,5-pyridinedicarboxylate and
valsartan is (2S)-3-methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl) phenyl] phenyl] methyl] amino]
butanoic acid are done by using UV spectroscopy. UV spectroscopy is based on the absorption of
visible light or UV light by pharmacological molecules. Normally, the research of UV spectroscopy
follows Beers Lambert's rule, therefore Q analysis was used to estimate the (AUC) area under curve
for amlodipine besylate and the standard curve for valsartan at the same time. Amlodipine besylate
has a lambda max of 240 nm, while valsartan has a lambda max of 250 nm. Determination is done by
immersing the mixed dosage in the methyl alcohol and calibration. Following this step, it undergoes
validation processes such as linearity, range, accuracy, precision, LOD (Loss of detection), LOQ
(Loss of quantification), assay, stability parameter studies, and regression value is also found. Hence,
this study explains about the quantitative estimation of amlodipine besylate and valsartan by UV
spectroscopy method for the identification of trace metals. Additionally, validation of test processes is
done to verify the potency of drug substances and also reveals the potency of fixed oral dosage form.
Keywords: Amlodipine besylate, Valsartan, UV Spectrophotometry, Validation, Fixed dose
Publication date: 01/05/2023
https://ijbpas.com/pdf/2023/May/MS_IJBPAS_2023_7139.pdf
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https://doi.org/10.31032/IJBPAS/2023/12.5.7139
