Abstract

Method development and validation of LC and Densitometric-TLC for simultaneous estimation of rosuvastatin calcium and ezetimibe in combined dosage forms

Author(s): Hiral J. Panchal and Bhanubhai N. Suhagia

Two simple and accurate methods to determine rosuvastatin calcium (ROS) and ezetimibe (EZE), in combined dosage form, were developed and validated using liquid chromatography (LC) and densitometric-thin layer chromatography (TLC). The LC separation was achieved on a Phenomenex Luna C18 column (250 mm, 4.6mm i.d., 5μm), in the isocratic mode using 0.65 M ammonium acetate buffer: methanol: acetonitrile: (30: 40: 30, v/v/v), pH 7.2 ± 0.05 at a flow rate of 1 mL/min. The retention times were about 3.60 and 6.99 min for ROS and EZE, respectively. Quantification was achieved with Photodiode array (PDA) detector at 239 nm over the concentration range of 0.5-5 μg/mL for each, with recoveries in the range of 98.91-99.82 % and 99.27-100.12 % for ROS and EZE, respectively. The TLC separation was achieved on silica gel 60 F254 HPTLC plates using toluene: acetone: glacial acetic acid (64.6: 35.0: 0.4, v/v/v), as the mobile phase. The Rf values were about 0.39 and 0.72 for ROS and EZE, respectively. Quantification was achieved with ultraviolet (UV) detection at 239 nm over the concentration range of 50-500 ng/spot for each, with recoveries in the range of 98.92-100.09 % and 98.80-100.01 % for ROS and EZE, respectively. Both methods were validated, and the results were compared statistically. They were found to be simple, specific, accurate, precise and robust. The methods were successfully applied for the determination of ROS and EZE in Combined dosage form without any interference from common excipients.

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