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VOL. 8, ISSUE 4 (2023)
Chemo metric assisted spectrophotometric method development through QBD approach for the estimation of Azilsartan Medoxomil and Cilnidipine in combined solid dosage form
Authors
G K Dyade, Shubham B Babare, Seema S Bansode
Abstract
Quality by design (QbD) is a systematic
process for pharmaceutical development recommended by regulatory agencies like
USFDA. Development of various pharmaceutical processes including analytical
methods by applying Quality by design aids in ensuring the robustness of the
method. QbD approached chemo metric assisted UV-VIS spectrophotometric
analytical method was developed for the estimation of Azilsartan medoxomil
(ASM) and cilnidipine (CDE) from the combined dosage forms. Simultaneous
equation method was selected from the nature of spectra, solvent 90 % alcohol
was utilised; and for method 241 nm and 356.6 nm was the wavelength for measurement
of absorbance of azilsartan and cilnidipine respectively. Effect of input
variables on spectrum characteristics were studied for selection of critical
parameters and developed method was validated as per ICH Q 2 R1 regulatory
guidelines. Linearity of the drugs was ascertained over the conc range 1-20
mcg/ml (microgram/ml) for CDE and 1-32 mcg/ml for ASM. The percentage purity of
assay was found 102.63 % for ASM and 99.65 % for CDE; and the accuracy study
data were varied from 0.15759 to 1.26401 for ASM and 0.21761 to 0.49314 for
CDE. Precision study was shown acceptable data as % RSD data varied from 0.6369
to 1.3192 for ASM and from 1.08653 to 1.34269 for CDE. The developed method is
rigid, robust and efficient for the estimation of ASM and CDM from the
composition of dosage form. QbD was applied to build rigid robust method
through risk assessment at early stage and defining the design space at the
later stage.
Pages:30-36
How to cite this article:
G K Dyade, Shubham B Babare, Seema S Bansode "Chemo metric assisted spectrophotometric method development through QBD approach for the estimation of Azilsartan Medoxomil and Cilnidipine in combined solid dosage form". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 8, Issue 4, 2023, Pages 30-36
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