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Method Development and Validation for the Estimation of Aliskiren in Pharmaceutical Dosage Form by RP-HPLC

Author

Listed:
  • Yadav Nita

    (Department of Pharmacy, SRMSCET, India)

  • Goyal Anju

    (B N Institute of Pharmaceutical Sciences, India)

Abstract

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Aliskiren in tablet dosage form. A C8 Chromasil column (150 × 4.6 mm, 5μm particle size) was used as a stationary phase with a mobile phase containing a mixture of phosphate buffer, methanol and ACN in ratio of 55:10:35, v/v. The flow rate was 1.0 mL/min. The effluent was monitored at 220 nm and eluted at 2.342 min. Calibration curve was plotted with a range from 30-150 μg/ml for Aliskiren and the correlation was found to be 0.999. The accuracy range was found between 100.06-100.43%. The % RSD values for both intraday and interday precision were less than 2.0. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 2.335μg/ml and 7.077μg/ml respectively. The assay was validated for the parameters like system suitability, precision, accuracy, and robustness parameters. The proposed method can be useful for the routine determination of Aliskiren in pharmaceutical dosage form.

Suggested Citation

  • Yadav Nita & Goyal Anju, 2018. "Method Development and Validation for the Estimation of Aliskiren in Pharmaceutical Dosage Form by RP-HPLC," Organic & Medicinal Chemistry International Journal, Juniper Publishers Inc., vol. 5(3), pages 86-90, February.
    • Handle: RePEc:adp:jomcij:v:5:y:2018:i:3:p:86-90
    DOI: 10.19080/OMCIJ.2018.05.555663
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