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ISSN 2063-5346
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Analytical Method Development And Validation Of Amlodipine And Celecoxib 10/200mg Tablets As Per Ich Guidelines

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Logeshwari T, Marina Juliet A, Deepak M, Vijey Aanandhi M
» doi: 10.31838/ecb/2023.12.1.326

Abstract

A simple, novel, sensitive, rapid high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for quantitative determination of Amlodipine and Celecoxib in combined dosage. Methods: The chromatographic development was carried out on RP-HPLC. The column used Agilent (Eclipse XDB-phenyl 250 x 4.6 x 5µm) or equivalent with mobile phase consisting of500mL of Acetonitrile, 500mL of milli-Q water and 2mL of Trifluoroacetic acid. The flow rate was 1.5 mL/min and the effluents were monitored at 238 nm. Results: The retention time was found to be Amlodipine about 3.0 minutes and Celecoxib about 8 minutes. The method was validated as per International Conference on Harmonization Guideline with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 1–10 μg/mL with a Amlodipine and Celecoxib regression coefficient were found to be 0.9998 and 0.9999 respectively. The method has proved high sensitivity and specificity. Conclusion: The results of the study showed that the proposed RP-HPLC method was simple, rapid, precise and accurate which is useful for the routine determination of Amlodipine and Celecoxib in combined dosage in its pharmaceutical dosage form.

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