RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF DILOXANIDE FUROATE AND ORNIDAZOLE IN TABLETS

Authors

  • P. Sivaprasad Chandra Labs, 5-5-35/173, Plot No-10, 1st Floor, IDA Prasanthi Nagar, Kukatpally, Hyderabad
  • S. Yaswanth Kumar Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • A. Ashok Kumar Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Keywords:

RP-HPLC, Diloxanide furoate, Ornidazole, Method development, Validation

Abstract

Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in tablets and validate as per ICH guidelines.

Methods: The optimized method uses a reverse phase C18 column, ZODIAC (250 X 4.6 mm; 5μ), mobile phase consisting of mixed phosphate buffer (KH2PO4 and K2HPO4): acetonitrile in the proportion of 30:70 v/v. The mobile phase was set at a flow rate of 1.0 ml/min and the volume injected was 20μl for every injection. The detection wavelength was set at 279 nm.

Results: The developed method resulted in Diloxanide furoate eluting at 4.293 min and Ornidazole at 3.34 min. Diloxanide furoate exhibited linearity in the range 90-210μg/ml, while Ornidazole exhibited linearity in the range 60-140μg/ml. The precision is exemplified by relative standard deviations of 0.97% for Diloxanide furoate and 0.3% for Ornidazole. Percentage Mean recoveries were found to be in the range of 98â€102, during accuracy studies. The limit of detection (LOD) for Diloxanide furoate and Ornidazole were found to be 8.80µg/ml and 6.68µg/ml respectively, while limit of quantitiation (LOQ) for Diloxanide furoate and Ornidazole were found to be 26.6µg/ml and 20.25µg/ml respectively.

Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in Amicline plus tablets and validated as per ICH guidelines. Hence it can be used for the routine analysis of Diloxanide furoate and Ornidazole in tablets in various pharmaceutical industries.

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Author Biographies

S. Yaswanth Kumar, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

M.Pharmacy Student; department of Pharmaceutical Analysis and Quality assurance

A. Ashok Kumar, Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Professor and Head of the department of Pharmaceutical Analysis and Quality assurance

 

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Published

01-02-2015

How to Cite

Sivaprasad, P., S. Yaswanth Kumar, and A. A. Kumar. “RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF DILOXANIDE FUROATE AND ORNIDAZOLE IN TABLETS”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 2, Feb. 2015, pp. 515-9, https://mail.innovareacademics.in/journals/index.php/ijpps/article/view/3538.

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