DEVELOPMENT AND VALIDATION OF STABILITY INDICTING ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY UPLC
Abstract
A stability indicating RP-UPLC method was developed and validated for simultaneous estimation Ofloxacin and Ornidazole in tablet dosage form. The separation was achieved under optimized chromatographic condition on a Waters® C18 Acquity UPLC BEH (100 mm × 2.1 mm, 1.7μm) column with mobile phase consist of Water: Acetonitrile: Triethylamine in the ratio of 85: 15: 0.1 v/v. An isocratic elution at a flow rate of 0.2 ml/min at ambient oven temperature was carried out with PDA detection at 300 nm. The retention time for Ofloxacin and Ornidazole was 3.9 min and 6.4 min respectively. The degradation was observed under acidic, alkali, oxidative, photolytic and thermal conditions. The linearity was found to be in the concentration range of 50-150μg/ml for Ofloxacin and 125-375μg/ml for Ornidazole. The % recoveries at 50% were found to be 100.46% & 100.22% for Ofloxacin & Ornidazole respectively. The % recoveries at 100% were found to be 99.70% & 99.83% for Ofloxacin & Ornidazole respectively. The % recoveries at 150% were found to be 99.67% & 100.30% for Ofloxacin & Ornidazole respectively. The method was validated as per ICH guideline and the values were found to be within the limits. So, the proposed method was found to be simple, linear, accurate, precise, stability indicating, robust and specific.
Keywords:
Ofloxacin, Ornidazole, Linearity, Forced Degradation, Method validationDOI
https://doi.org/10.25004/IJPSDR.2015.070411References
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27. Lalitha DM, Chandrasekhar KB. A Validated Stability-indicating RPHPLC method for Levofloxacin in the presence of degradation products, its process related impurities and identification of Oxidative degradant. J. Pharm Biomad Anal. 2009; 50: 710-717.
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33. Indian Pharmacopoeia 2010, Vol-III, The Indian Pharmacopoeial Commission, pp. 1824.
34. Fatma IK., Maha AH.-Stabilty-Indicating Methods for the Determination of Ornidazole in The Presence of its Degradate According to ICH Guidelines. J. Pharm. Anal., 2012; 3: 145-149.
35. Maheshwari RK, Anshu J. New Spectrophotometric Estimation of Ornidazole Tablets Employing Urea as a Hydrotropic Solubilizing Additive. Indian. J. Pharm. Sci. 2010; 72: 258-261.
36. Sevak MR, Patel NB, Patel KN. Development and validation of RP-UPLC method for simultaneous estimation of ofloxacin and ornidazole in their combined dosage form including stress study. IOSR Journal of Applied Chemistry (IOSR-JAC). 2014; 7(9) Ver. II.: 32-35.
2. Sinem YH, Zeynep AY, Mine O- Bioavailability File: Ornidazole. J. Pharm. Sci. 2004; 29: 133-144.
3. Sandra B, Alka JM- Determination of pKa values of active pharmaceutical ingredients: Trends in Anal Chem. 2007; 26: 1043-1051.
4. Mohammed A, Al-Omar. Profile of Drug Substances, Excipients, and Related Methodology: ofloxacin. Academic Press, Burlington, 2009.
5. Maryadele J. O’Neil. The Merck Index An Encyclopedia Of Chemicals, Drugs & Biologicals: Published by Merck Research Laboratories Division Of Merck & Co., INC, Whitehouse Station, NJ, USA, 2006.
6. Martindale. The Complete Drug Reference: Pharmaceutical Press, London-Chicago.
7. Indian Pharmacopoeia 2010. The Indian Pharmacopoeial Commission, pp. 1809, 1824.
8. US Pharmacopeia 32 NF 27. The United State Pharmacopoeial Convention, Rockville, pp. 3128-3129.
9. European Pharmacopoeia 7.0. European Directorate for the Quality of Medicines & HealthCare (EDQM), pp. 2609.
10. Japanese Pharmacopoeia XV. The Ministry of Health, Labour and Welfare, pp. 939.
11. World Health Organization 2010, Ofloxacin Draft Proposal for the International Pharmacopoeia, pp. 1-7.
12. ICH QIA (R2). 2005 Stability Testing of New Drug Substances and Products, 2012.
13. Singh S, Bakshi M. Guidance on Conduct of Stress Tests to Determine Inherent Stability of Drugs. J Pharm Tech. 2000; 28: 1-14.
14. Hildegard. How to approach a Forced Degradation Study. Life Science Technical Bulletin. 2011; 31:1-4.
15. Singh S, Bakshi M. Development of validated stability-indicating assay methods-critical review. J Pharm and Biomed Anal. 2002; 28:1011-1040.
16. ICH Q2A. 2005 Validation of Analytical Method, November 2012.
17. Skoog DA, Holler FJ, Nieman TA. In An Introduction to Analytical Chemistry: Thomson Brooks/Cole Publication, Singapore, 1994.
18. Jeffery G, Bassett J, Mehdham J, Denney R. In Text of quantitative Chemical Analysis: John Willey and sons INC, New York, 1989.
19. Swarbrick J, Boylan J. In Encyclopedia of pharmaceutical technology: Marcel Dekker Inc, 2002.
20. Mendham J, Denny R, Barnes J. Thomas M. In Vogels Text Book of Quantitative Chemical Analysis: Pearson education, 2002.
21. Snyder L, Kirkland J. In Introduction to Modern Liquid Chromatography: John Wiley & Sons Inc, New York, 1997.
22. Michael A. Swartz. Ultra Performance Liquid Chromatography (UPLC): An Introduction, 2005, www.chromatographyonline.com
23. Ahuja S, Scypinski S. In Handbook of Modern Phamaceutical Analysis: Academic Press, United States of America, 2001.
24. Syed NR, Muhhammad A, Islam UK. Stability indicating HPLC method for the simultaneous determination of Ofloxacin and Ketorolac tromethamine in Pharmaceutical Formulations. Anal. Methods. 2012; 4: 2121-2126.
25. Arun KD, Shiva TK. A Validated UV-Spectrophotometric Method for the Estimation of Ofloxacin in Bulk and Pharmaceutical Dosage Form. International J Pharm. Biotech. 2011; 2: 1157-1161.
26. Gandhi VN. Analytical Method Development and Validation Of Ofloxacin Eye Drop by HPLC. J Curr. Chem Pharm. Sc. 2011; 1: 59-64.
27. Lalitha DM, Chandrasekhar KB. A Validated Stability-indicating RPHPLC method for Levofloxacin in the presence of degradation products, its process related impurities and identification of Oxidative degradant. J. Pharm Biomad Anal. 2009; 50: 710-717.
28. Kareti SR, Nargesh K. Spectrophotometric methods for the simultaneous estimation of Ofloxacin & Tinidazole in bulk and pharmaceutical dosage form. Ind. J Pharm. Sc. 2011; 2: 98 102.
29. Mahesh YA. A Conventional HPLC-MS method for the simultaneous determination of Ofloxacin & Cefexime in Development and Validation. J Basic Clin. Pharm. 2013; 4: 36-41.
30. Ekram MH, Ruba NS. Stability-Indicating Spectrophotometric Methods for the Determination of Ofloxacin and Ceftriaxone and Their Degradation Products. J Pharm. Biomed. Sc. 2012; 18: 1-13.
31. Wankhede SB, Prakash A, Chitlange SS. Simultaneous Spectrophotometric Estimation of Ofloxacin & Satranidazole in Tablet Dosage Form. Asian J. Research Chem. 2008; 1: 9-11.
32. Mohammed SA. Simultaneous Determination of Ofloxacin, Tetrahydrozolide Hydrochloride and Prednisolone Acetate by HPLC. J Chromatographic. Sc. 2002; 40: 429-433.
33. Indian Pharmacopoeia 2010, Vol-III, The Indian Pharmacopoeial Commission, pp. 1824.
34. Fatma IK., Maha AH.-Stabilty-Indicating Methods for the Determination of Ornidazole in The Presence of its Degradate According to ICH Guidelines. J. Pharm. Anal., 2012; 3: 145-149.
35. Maheshwari RK, Anshu J. New Spectrophotometric Estimation of Ornidazole Tablets Employing Urea as a Hydrotropic Solubilizing Additive. Indian. J. Pharm. Sci. 2010; 72: 258-261.
36. Sevak MR, Patel NB, Patel KN. Development and validation of RP-UPLC method for simultaneous estimation of ofloxacin and ornidazole in their combined dosage form including stress study. IOSR Journal of Applied Chemistry (IOSR-JAC). 2014; 7(9) Ver. II.: 32-35.
Published
01-07-2015
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“DEVELOPMENT AND VALIDATION OF STABILITY INDICTING ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY UPLC”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 4, July 2015, pp. 365-9, https://doi.org/10.25004/IJPSDR.2015.070411.
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How to Cite
“DEVELOPMENT AND VALIDATION OF STABILITY INDICTING ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF OFLOXACIN AND ORNIDAZOLE IN TABLET DOSAGE FORM BY UPLC”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 7, no. 4, July 2015, pp. 365-9, https://doi.org/10.25004/IJPSDR.2015.070411.
