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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 9
First page : ( 4280) Last page : ( 4284)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00756.8

Development and validation of analytical method for simultaneous estimation of amlodipine besylate and celecoxib in pure and combined dosage form

Mandale Tejaswini Rajaram1,*, Kondawar Manish. S.2, Kadam Sandeep Dilip1

1Department of Quality Assurance, ABCP, Sangli-416416, Maharashtra, India

2Head of Department of Quality Assurance, ABCP, Sangli-416416, Maharashtra, India

*Corresponding Author E-mail: tejaswinimandale12@gmail.com

Online published on 16 September, 2020.

Abstract

A simple, rapid and reliable UV spectroscopic method was developed and validated for simultaneous estimation of Amlodipine besylate (Amlo) and Celecoxib (Celo) in pure and combined dosage form. Amlo and Celo shows absorption maximum in methanol at 237nm and 252nm respectively. According to ICH guidelines, this method was validated for linearity, precision, accuracy, limit of detection and Limit of quantitation. This method showed linearity and correlation coefficient for Amlo and Celo as 2 to 12μg/ml, 0.9981 and 0.9984 respectively. The recovery studies for Amlo and Celo was obtained to be 100.5 to 101.66% and 100.28% to 101% respectively. The precision of method were established by repeatability study. Limit of detection and Limit of quantitation are 0.21μg/ml and 0.64μg/ml for Amlo and 0.12μg/ml and 0.36μg/ml for Celo respectively. The statistical parameters and recovery data presented that the method may be engaged for efficient, rapid examination of both drugs the from tablet formulation. The percentage label claim present in formulation tablet was obtained to be 99% and 100.3% for Amlo and Celo respectively. These analysis is clearly specified that without there interference from excipients in the formulation.

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Keywords

Amlodipine besylate, Celecoxib, Methanol, Simultaneous equation method, UV Spectroscopy.

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