A Method Development and Validation of Rabeprazole Sodium (API) by High-Performance Liquid Chromatography

نویسندگان

  • Tushar G. Barot
  • Vipul Prajapati
  • P. K. Pate
  • D. K. Bhoi
چکیده

A simple and accurate methods to determine Rabeprazole sodium, in pure powder and tablet dosage form, were developed and validated using liquid chromatography (LC). The LC separation was achieved on a Inertsil ODS 3V, 150 x 4.6 mm, 5μ in the isocratic mode using buffer : acetonitrile (65 : 35, v/v), adjusted to pH 6.00 ± 0.05 with dilute KOH , as the mobile phase at a flow rate of 1.5 ml/min. the methods were performed at 280 nm; In LC method, quantification was achieved with PDA detection over the concentration range of 80 to 120 μg/ml. The methods were validated, and the results were compared statistically. They were found to be simple, accurate, precise, and specific. The methods were successfully applied for the determination of Rabeprazole sodium in pure powder and Tablet dosage form without any interference from common excipients.

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تاریخ انتشار 2009