A Validated RP-HPLC Method for the Estimation of Ornidazole in Pharmaceutical Dosage Forms

Abstract

Anew, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay has been developed and validated for assay of Ornidazole in tablet formulations. Tinidazole was used as an internal standard. These compounds are separated well on a X-Terra Waters Corp., Milford, MA, USA RP-18 column by using a mobile phase consisting of a mixture of acetonitrile : water 30:70; v/v adjusted to pH 3.00 with 10 mM o-phosphoric acid at a flow rate of 1.0 mL min-1. The method was validated as per the ICH guidelines.

Keywords

• Ornidazole,RP-LC,Validation,Pharmaceutical Dosage Forms

Ornidazol’ün Farmasötik Dozaj Formlarından Valide Edilmiş RP-HPLC Metodu ile Belirlenmesi

Abstract

O rnidazol için yeni, kolay, seçici, kesin ve doğru, izokratik ters faz sıvı kromatografik metot geliştirilmiş ve tablet formülasyonlarından miktar tayini için valide edilmiştir. Tinidazol iç standart olarak kullanılmıştır. Bu bileşikler için ayırma, X-Terra Waters Corp., Milford, MA, USA RP-18 kolonu ve mobil faz olarak 10 mM o-fosforik asit içeren pH 3’e ayarlanmış 30:70 v/v asetonitril-su karışımı kullanılarak 1.0 mL dakika-1 akış hızında gerçekleştirilmiştir. Metot ICH kurallarına göre valide edilmiştir

Keywords

• Ornidazol, RP-LC, Validasyon, Farmasötik Doz Formları

References

1. 1. S. Budavari Eds. In. The Merck Index. (Merck & Co.,Inc), Whitehouse Station, NJ. 2001, 13th Ed:1213 and 1229.
2. 2. R.K. Nanda, J. Gaikwad, A. Prakash, A, Simultaneous spectrophotometric estimation of cefixime and ornidazole in tablet dosage, Int. J. PharmTech Res., 1 (2009) 488.
3. 3. V.S. Kasture, A.P. Bhagat, Puro N.C, Simultaneous Estimation of Ornidazole and Ofloxacin by Derivative Spectrophotometry Method, Indian Drugs, 41 (2004) 51.
4. 4. S.P. Wate, H. Nimje, M. Ramtake, Simultaneous Spectrophotometric Estimation of Gatifloxacin and Ornidazole in Tablets, Indian J. Pharm. Educ. Res., 41 (2007) 236.
5. 5. B. Dhandapani, N. Thirumoorthy, S.H. Rasheed, M. Rama Kotaiah, N. Anjaneyalu, Method Development and Validation for the Simultaneous Estimation of Ofloxacin and Ornidazole in Tablet Dosage Form by RP-HPLC, Int. J. Pharm. Sci. & Res., (IJPSR) 1 (2010) 78.
6. 6. N.S. Kamble, A. Venkatachalam, High Performance Liquid Chromatography Determination of Ornidazole and Ofloxacin in Solid Dosage Form, Indian Drugs, 42 (2005) 723.
7. 7. D. Nagavallai, A.S. Sankar, Anandakumar, K. Karunambigni, M.S.S.N Raja, Reverse Phase-HPLC Method For Simultaneous Estimation Of Gatifloxacin And Ornidazole in Tablets, Indian J. Pharm. Sci., 69 (2007) 333.
8. 8. P. Heizmann, Geschke, K. Zinapold, Determination of Ornidazole and its Main Metabolites in Biological Fluids, J. Chromatogr. B, 534 (1990) 233.

9. 9. S.A. Ozkan, Z. Senturk, I. Biryol, Determination of Ornidazole in Pharmaceutical Dosage Forms Based on Reduction at an Activated Glassy Carbon Electrode, Int. J. Pharm, 157 (1997) 137.
10. 10. S. Rondinini, P.R. Mussini, T. Mussini, Reference Value Standards and Primary Standards for pH Measurements in Organic Solvents and Water + Organic Solvent Mixtures of Moderate to High Permittivities, Pure Appl. Chem., 59 (1987) 1549.
11. 11. P.R. Mussini, T. Mussini, S. Rondinini, Reference Value Standards and Primary Standards for pH Measurements in D2O and Aqueous-organic Solvent Mixtures: New Accessions and Assessments (Technical Report), Pure Appl. Chem., 69 (1997) 1007.
12. 12. Schwartz DE, Jeunet F. Comparative Pharmacokinetic Studies of Ornidazole and Metronidazole in Man, Chemother., 22 (1976) 19.
13. 13. R. Mc Nally, The United States Pharmacopoeia, 24th revision, Taunton, M.A., Easton, 2000.
14. 14. J. Ermer, J.H. Miller, Method validation in pharmaceutical analysis, 1st Edn. Wiley-VCH Pub, Germany, 2005.
15. 15. M.E. Swartz, I.S. Krull, Analytical Method Development and Validation, Marcel Dekker, New York, 1997.
16. 16. Topic Q2A, Validation of Analytical Procedures: Methodology, International Conference on Harmonization, Brussels, Belgium, 1995.
17. 17. C.M. Riley, T.W. Rosanske, Development and Validation of Analytical Methods, Elsevier, Amsterdam, Netherlands, 1996.