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Determination of Related Substances in Simvastatin Tablets by HPLC

Yuzhen Zhang

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Abstract

The HPLC method for determination of related substances in simvastatin tablets was established. A VP-ODS(250mm×4.6mm,5μm) column was used with the mobile phase of acetonitrile-0.025mol/L sodium dihydrogen phosphate solution(pH4.5) (65:35),at the detection wavelength of 238nm and the column temperature of 35℃.The flow rate was 1.0ml/min.The calibration curve was linear in the ranger of 0.1-3.0μg/ml (r=0.9999). The determination limit was 0.2μg.

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What this paper is about

The HPLC method for determination of related substances in simvastatin tablets was established. A VP-ODS(250mm×4.6mm,5μm) column was used with the mobile phase of acetonitrile-0.025mol/L sodium dihydrogen phosphate solution(pH4.5) (65:35),at the detection wavelength of 238nm and the column temperature of 35℃.The flow rate was 1.0ml/min.The calibration curve was linear in the ranger of 0.1-3.0μg/ml (r=0.9999). The determination limit was 0.2μg.

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Available abstract

The HPLC method for determination of related substances in simvastatin tablets was established. A VP-ODS(250mm×4.6mm,5μm) column was used with the mobile phase of acetonitrile-0.025mol/L sodium dihydrogen phosphate solution(pH4.5) (65:35),at the detection wavelength of 238nm and the column temperature of 35℃.The flow rate was 1.0ml/min.The calibration curve was linear in the ranger of 0.1-3.0μg/ml (r=0.9999). The determination limit was 0.2μg.

Key concepts: Chromatography, Simvastatin, Calibration curve, High-performance liquid chromatography, Acetonitrile, Chemistry, Detection limit, Sodium

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