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Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM BY UV SPECTROPHOTOMETRIC METHOD USING MIXED HYDROTROPIC PHENOMENA

Avanish Kumar*, Pushpendra Soni, Lavakesh K Omray

Radharaman Institute of Pharmaceutical Sciences, Bhopal (M.P)

ABSTRACT

A novel, simple, fast and reproducible UV spectrophotometric method was developed using 2M Sodium Benzoate: 2M Sodium acetate as hydrotropic solubilizing agent for the estimation of poorly water soluble drug Amlodipine besylate (AMD) and Atorvastatin calcium (ATV) in bulk and in pharmaceutical dosage form. After solubilising the Amlodipine besylate and Atorvastatin calcium in the selected hydrotropic agent, it was scanned in spectrum mode and Amlodipine besylate and Atorvastatin calcium showed linearity in the concentration range of 2-10 g/ml and 5-25g/ml at their respective maxima was selected as wavelength for estimation, considering the reproducibility and variability of the obtained result. The developed method was found to be linear in the range of 2-10 g/ml and 5 to 25μg/ml and with correlation coefficient (r2) of 0.999 and linear equation was Y=0.056X-0.002 and Y=0.002X-0.000 for Amlodipine besylate and Atorvastatin calcium. The mean percent label claims of synthetic mixture of Amlodipine besylate and Atorvastatin calcium in formulation estimated by the proposed method were found to be 99.046±0.284 to 99.828±0.308 and 98.18±0.386 to 98.40±0.706. These values are close to 100,indicating the accuracy of the proposed analytical method. Low values of standard deviation, percent coefficient of variation and standard error further validated the proposed method. Also the values of standard deviation, percent coefficient of variation and standard error were satisfactorily low. Result of precision at different level were found be within acceptable limits (RSD ‹ 2). Therefore, the methods can be used for routine monitoring of Amlodipine besylate and Atorvastatin calcium in industry in the assay of bulk drug and tablets.

Keywords: Amlodipine besylate and Atorvastatin calcium, Hydrotropy, Sodium acetate, Sodium Benzoate, Spectrophotometry.


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