Zeitschrift für Chromatographie und Trenntechniken

Zeitschrift für Chromatographie und Trenntechniken
Offener Zugang

ISSN: 2157-7064


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

Mallikarjuna S, Ramalingam P, Sriram P, Garima J and Srinivas SK

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.