alexa Development and Validation of Stability-Indicating RP-U
ISSN: 2157-7064

Journal of Chromatography & Separation Techniques
Open Access

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Research Article

Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Dosage Forms

Mallikarjuna S1*, Ramalingam P1, Sriram P2, Garima J2 and Srinivas SK2

1Raghavendra Institute of Pharmaceutical Education & Research (RIPER), Anantapur, India

2Daiichi Sankyo India Pharma Private Limited, Gurgaon, India

*Corresponding Author:
Mallikarjuna S
Raghavendra Institute of Pharmaceutical
Education & Research (RIPER)
Anantapur, India
E-mail: [email protected]

Received Date: May 13, 2013; Accepted Date: June 26, 2013; Published Date: June 28, 2013

Citation: Mallikarjuna S, Ramalingam P, Sriram P, Garima J, Srinivas SK (2013) Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Estimation of Amlodipine Besylate and Atorvastatin Calcium in Pharmaceutical Dosage Forms. J Chromatograph Separat Techniq 4:187. doi: 10.4172/2157-7064.1000187

Copyright: © 2013 Mallikarjuna S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

A stability indicating Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the simultaneous determination of Atorvastatin Calcium (ASC) and Amlodipine Besylate (AMB) in tablets. The chromatographic separation was performed on acquity UPLC, Kromasil C18, 50×2.1 mm, 3.5 μm using gradient elution of acetonitrile and 0.1% v/v Triethyl amine buffer (pH 3 ± 0.05) at flow rate of 0.8 ml/min. UV (Ultra Violet) detection was performed at 240 nm. Total run time was 2.2 min within which main compounds and degradants were separated. Stability indicating capability was established by forced degradation experiments. The method was validated for accuracy, repeatability, reproducibility and robustness. Linearity, Limit of Quantification (LOQ) and Limit of Detection (LOD) was also established.

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