Development, Validation of a stability indicating method for the simultaneous determination of Levofloxacin hemihydrate and Ornidazole by High Performance Liquid Chromatography

Authors

  • Anusha Nadukuru Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.
  • T. Santosh Kumar Pharmaceutical Research & Development Laboratory, Corpuscle Research Solutions, Visakhapatnam-530003, India.

Keywords:

Levofloxacin hemihydrate, Ornidazole, HPLC

Abstract

A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Levofloxacin hemihydrate and Ornidazole in pharmaceutical Tablet dosage form. The mobile phase consisted of  70:30% (v/v) of Methanol & 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 0.6 ml/min. Chromatographic separation of Levofloxacin hemihydrate and Ornidazole was performed on PHENOMENEX ION PAIR C18 column (150 X 4.6 mm id, ODS 2, 5µm). The wavelength of detection is 290 nm. The injection volume is 20µL. The retention time of Levofloxacin hemihydrate and Ornidazole are 2.4 ± 0.10 minutes and 3.8 ± 0.10 respectively. The run time of analysis is 6.2 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The influence of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs was studied. Results indicated complete degradation in alkaline medium for Levofloxacin hemihydrate and Ornidazole. The proposed method has been successfully used for the estimation in tablet dosage forms.

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References

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Published

2013-10-31
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Anusha Nadukuru, and T. S. K. T. Santosh Kumar. “Development, Validation of a Stability Indicating Method for the Simultaneous Determination of Levofloxacin Hemihydrate and Ornidazole by High Performance Liquid Chromatography”. International Journal of Pharmaceutics and Drug Analysis, vol. 1, no. 1, Oct. 2013, pp. 37-48, https://ijpda.com/index.php/journal/article/view/2.

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