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Research Journal of Pharmacy and Technology
Year : 2017, Volume : 10, Issue : 10
First page : ( 3379) Last page : ( 3385)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2017.00601.1

RP-HPLC Method for the Simultaneous Estimation and Validation of Amlodipine Besylate and Atenolol in Bulk and Tablet Dosage Form in Biorelevant Dissolution Medium (Fassif)

Shanmugasundaram Palani1,*, Kamarapu S. K2,**

1Director, School of Pharmaceutical Sciences, VISTAS, Vels University, Chennai, Tamilnadu, India

2Research Scholar, Department of Pharmaceutical Analysis, School of Pharmaceutical Sciences, VISTAS, Vels University, Chennai, Tamilnadu, India

*Corresponding Author E-mail: director.sps@velsuniv.ac.in

**E-mail: kamarapu.sudheerkumar@gmail.com

Online published on 26 March, 2018.

Abstract

Objective

A simple, rapid, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous analysis of Amlodipine Besylate and Atenolol in a tablet dosage form and in Biorelevant media has been developed and validated.

Methods

The chromatographic separation was achieved using reverse phase C18 column; Kromasil C18 column (250 mm x 4.6 mm x 5μm). The mobile phase used was a mixture of Acetonitrile: Potassium di hydrogen phosphate solution (0.01M, pH 3.0 adjusting with Ortho phosphoric acid): Methanol (15: 30: 55) at isocratic mode and eluents were monitored at 254 nm using PDA detector.

Results

By the method Amlodipine Besylate and Atenolol were eluted with retention times of 2.589 and 3.711 min, respectively. The method was continued and validated accordance with ICH guidelines. Validation revealed the method is rapid, specific, accurate, precise, reliable, and reproducible. Calibration curve plots were linear over the concentration ranges 25–125μg/mL for Amlodipine Besylate, 5–25μg/mL for Atenolol. Limits of detection (LOD) were 0.001, and 0.005μg/ml and limits of quantification (LOQ) were 0.004 and 0.015μg/mL for Amlodipine Besylate and Atenolol respectively.

Conclusion

The statistical analysis was proves the method is suitable for the analysis of Amlodipine Besylate and Atenolol as a bulk and tablet dosage form in biorelevant dissolution media (Fasted State Simulated Intestinal Fluid-FaSSIF) without any interference from the excipients.

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Keywords

Amlodipine Besylate and Atenolol, RP-HPLC, Validation, Biorelevant media (FaSSIF).

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