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

Authors

  • P. SWETHA Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • D. Vijay Kumar Jawaharlal Nehru technological University, Hyderabad (JNTUH)
  • B. RAKESH Jawaharlal Nehru technological University, Hyderabad (JNTUH
  • A. ASHOK KUMAR Jawaharlal Nehru technological University, Hyderabad (JNTUH)

Keywords:

RP-HPLC, Diloxanide furoate, Tinidazole, 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 Tinidazole in tablets and validate as per ICH guidelines.

Method: The optimized method uses a reverse phase column, Waters Symmetry C18 (250 X 4.6 mm;5μ), a mobile phase of triethylammonium phosphate buffer (pH 2.3):acetonitrile in the proportion of 40:60 v/v, flow rate of 1.0ml/min and a detection wavelength of 270 nm using a UV detector.

Results: The developed method resulted in Diloxanide furoate eluting at 4.07min and Tinidazole at 2.52min. Diloxanide furoate exhibited linearity in the range 31.25-93.75μg/ml, while Tinidazole exhibited linearity in the range 37.5-112.5μg/ml. The precision is exemplified by relative standard deviations of 0.90% for Diloxanide furoate and 0.68% for Tinidazole. 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 Tinidazole were found to be 68.53µg/ml and 97.87µg/ml respectively, while limit of quantitiation (LOQ) for Diloxanide furoate and Tinidazole were found to be 207.677µg/ml and 296.6µg/ml respectively.

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

 

Downloads

Download data is not yet available.

References

Sirisha T, Gurupadayya BM, Sridhar S. Simultaneous determination of Ciprofloxacin and Tinidazole in tablet dosage form by reverse phase high performance liquid chromatography. Trop J Pharm Res 2014;13:981-7.

Danao KR, Hiradeve SM, Moon RS, Kasture AV, Yeole PG. RP-HPLC simultaneous estimation of Metronidazole and Diloxanide furoate in combination. Int J Pharm Life Sci 2010;1:82-5.

McAuley JB, Herwaldt BL, Stokes SL, Becher JA, Roberts JM, Michelson MK, et al. Diloxanide furoate for treating asymptomatic Entamoeba histolytica cyst passers: 14 y experience in the United States. Clin Infect Dis 1992;15:464-8.

Marsden PD. Treatment of cyst passers. Clin Infect Dis 1992;15:559.

Ata AH, El-Haieg MO, Aboul-Magd LA, Mansour AH. A comparative study on some anti-amoebic drugs in cyst-passers. J Egypt Soc Parasitol 1984;14:213-8.

Walash MI, Ibrahim F, El Abass S. Isocratic RP-HPLC method for separation and simultaneous determination of ternary mixture of Omeprazole, Tinidazole and Doxycycline in their raw materials and combined capsules. Anal Methods 2013;5:5105-11.

Sebaiy MM, El-Shanawany AA, Adl SM, Abdel-Aziz LM, Hashem HA. Rapid RP-HPLC method for simultaneous estimation of Norfloxacin and Tinidazole in tablet dosage form. Asian J Pharm Anal 2011;1:79-84.

Vikas K, Senthil kumar M, Mahadevan N. Simultaneous estimation of Amoxicillin, Tinidazole and Omeprazole in microsphere formulation by RP-HPLC. Int J Recent Adv Pharm Res 2012;2:78-83.

Meshram DB, Bagade SB, Tajne MR. Simple HPLC method for simultaneous estimation of Fluconazole and Tinidazole in combined dose tablet. J Chromatogr Sci 2009;47:885-8.

Chiranjeevi B, Swati B, Kalyan O. Novel reverse phase HPLC method development and validation of Fluconazole and Tinidazole in a combined tablet dosage form. Int J ChemTech Res 2011;3:1309-17.

Mahmoud MS, Abdullah AS, Sobhy MEA, Lobna MAA, Hisham AH. Rapid RP-HPLC method for simultaneous estimation of Norfloxacin and Tinidazole in tablet dosage form. Asian J Pharm Anal 2011;1:79-84.

Hackett LP, Dusci LJ. Determination of metronidazole and tinidazole in human plasma using high performance liquid chromatography. J Chromatogr 1979;175:347-9.

Satyabrata R. HPLC determination of Metronidazole and Diloxanide furoate in single and combined formulation. East Pharm 1994;2:131-3.

Rao GR, Murthy SSN, Mohan K. HPLC assay of Diloxanide furoate and Metronidazole in combined dosage forms. Indian Drugs 1983;21:455-7.

Gizawy EISM. HPLC analysis of Metronidazole and Diloxanide furoate in its dosage forms. Anal Lett 1995;28:83-92.

Mishal A, Sober D. Stability indicating reversed-phase liquid chromatographic determination of Metronidazole benzoate and Diloxanide furoate as bulk drug and in suspension dosage form. J Pharm Biomed Anal 2005;39:819-23.

Shaalan Al, Nora H. Determination of Diloxanide Furoate and Metronidazole in binary mixture using first derivative of the ratio-spectra and high-performance liquid chromatography-UV methods. Am J Appl Sci 2007;4:66-72.

Pai P, Rao GK, Srinivas B, Puranik S. RPLC determination of Tinidazole and Diloxanide furoate in tablets. Indian J Pharm Sci 2008;70:670-2.

Kartheek N, Kavitha N, Ashok Kumar A. RP-HPLC method development and validation for simultaneous quantitative estimation of Diloxanide furoate and Tinidazole in tablets. Int J Pharm Pharm Sci 2015;7:338-42.

International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Validation of analytical procedures: Text and methodology ICH Q2 (R1); 2005.

Published

01-12-2015

How to Cite

SWETHA, P., D. V. Kumar, B. RAKESH, and A. A. KUMAR. “ASSAY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF DILOXANIDE FUROATE AND TINIDAZOLE IN TABLETS BY RP-HPLC”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 12, Dec. 2015, pp. 30-35, https://journals.innovareacademics.in/index.php/ijpps/article/view/5159.

Issue

Section

Original Article(s)

Most read articles by the same author(s)

<< < 1 2 3 > >>