Chemo metric assisted Spectrophotometric Method Development through QBD Approach for the estimation of Metoprolol succinate and Cilnidipine in combined solid dosage form

Source of Support: Nil, Conflict of Interest: None declared

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DOI: 10.4103/2231-4040.197331

Regulatory agencies like USFDA has recommended implementation of Quality by design (QbD) a systematic process for pharmaceutical development along with its significance. 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 metoprolol succinate (MPS) and cilnidipine (CDE) from the combined dosage forms. Nature of spectra directed applicability of simultaneous equation and multicomponent methods for estimation of both drugs from the formulations; and 90 % alcohol was being the common solvent. For both this method 221 nm and 242 nm was the wavelength for measurement of absorbance of metoprolol 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 1-40 μg/ml (microgram/ml) for MPS and 1-20 μg/ml for CDE. The percentage purity of assay found in method II was found 102.21 % for MPS and 101.28 % for CDE; and the accuracy study data of method I were varied from 0.4366 to 0.8989 for MPS and 0.5534 to 1.3027 for CDE. Precision study was shown acceptable data as % RSD in method I data varied from 0.7119 to 2.5465 for MPS and from 0.5902 to 0.5919 for CDE. The developed method is rigid, robust and efficient for the estimation of MPS and CDM from the composition of dosage form.

Keywords: Metoprolo succinate, Cilnidipine, QbD, ICH, Multicomponent, simultaneous equation method