STABILITY INDICATING REVERSED PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF RELATED SUBSTANCES OF CITICOLINE AND PIRACETAM IN PHARMACEUTICAL DOSAGE FORM

Authors

  • Manutosh Acharya
  • Jain Ak
  • Navneet Garud

Abstract

ABSTRACT
Objective: A high-performance liquid chromatography (HPLC) method was developed and validated to determine stability indicating method of
Piracetam and Citicoline in a tablet dosage.
Methods: The separation was made using Inertsil C18, 250 × 4.6 mm, 5 µm column, mobile phase used contained phosphate buffer and acetonitrile
in the gradient mode at wavelength of 205 nm for Piracetam and 280 nm for Citicoline on a PDA detector.
Results: The method showed good linearity for, respectively related substances of Citicoline and Piracetam with correlation coefficients in the range
of 0.29-623 µg/mL and 0.48-1030 µg/mL, respectively. Method accuracy was assessed at three levels; the recovery ranged between 100.0% and 102%
for Citicoline and for Piracetam between 94.3% and 109.1%. Limit of detection and quantification for Citicoline was 0.07 µg/mL - 0.25 µg/ml and for
Piracetam 0.12 µg/mL - 0.41 µg/ml. The solution was found to be stable within 27 hrs at room temperature.
Conclusion: The method was demonstrated to be robust and simple, and suitable for industrial application for determination of related substances
in the pharmaceutical preparation.
Keywords: Piracetam, Citicoline, Assay, Reversed phase-high performance liquid chromatography.

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References

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Published

01-03-2016

How to Cite

Acharya, M., J. Ak, and N. Garud. “STABILITY INDICATING REVERSED PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF RELATED SUBSTANCES OF CITICOLINE AND PIRACETAM IN PHARMACEUTICAL DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, vol. 9, no. 2, Mar. 2016, pp. 292-7, https://mail.innovareacademics.in/journals/index.php/ajpcr/article/view/10660.

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