Development, Validation of a stability indicating method for the simultaneous determination of Levofloxacin hemihydrate and Ornidazole by High Performance Liquid Chromatography
Keywords:
Levofloxacin hemihydrate, Ornidazole, HPLCAbstract
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
Budavari S., Eds., In; The Merck index, 13th Edn.,merck & Co.,Inc.,white house station,NJ, 1998,3124.
Budavari S., Eds., In; The merck index, 12th Edn.,merck & co.,Inc.,white house station,NJ 1996,1178.
Nagori B.P., Shrivastava B.,Sharma V and Rajput A.S., Spectrophotometric Method for Simultaneous Estimation of Ofloxacin and Ornidazole in Tablet Dosage Form, Indian drugs,2006,43(10),676-678..
Somashekar M., Vidyasager J., Narsaiah N. Anand kumar R and Krishna D.R., Validated HPLC Method for the Determination of Ornidazole in Human Serum and Urine, Indian J.Pharm.Sci.,2005,67(3),302-306.
Groppi A.,Papa P.,Montagna M and Carosi G., Determination of Ornidazole in Human Plasma and RBCs Using HPLC,J.Chromatogr.,1986,380(2),42-437.
Kale U.N., Naidu K.R and Shingare M.S., Spectrophotometric Determination of Ornidazole and Norfloxacin in Tablets, Indian J. Pharm.Sci..,2003, 65(5), 439-556.
Abu., Zuhri A.Z., Voelter W., Al-Kahalil S and Salahat., Extractional Spectrophotometric Determination of Febendazole and Ornidazole in Pharmaceutical Formulations, J.Pharm.Sci.,,2000,68(1),109-122.
Kasture V.S., Bhagat A.D., Pure N.C., More P.S and Bandari N.K., Spectrophotmetric Method for Simultaneous Estimation of Ofloxacin and Ornidazole in Tablet Dosage Form, Indian drugs 2004,41(1),51-53.
Lakshmi Sivasubramaniam., Kasi Sankar V., Sivaraman V., Senthil Kumar V., Senthil Kumar K., Muthukumaran A., and Raja T.K, Visible Spectrophotometric Determination of Levofloxacin in Tablet Dosage Forms, Indian J.Pharm.Sci.2004,779-802.
Patel U.N., Suhagia B.N., Patel M.M., Gayathri C., Patel and Geetha M. Patel, Simultaneous Spectrophotometric Estimation of Gatifloxacin and Ornidazole in Mixture, Indian J.Pharm.sci, 2005, 67(3), 356-357.
Chepurwar S.B., Shirkedkar A.A., Bari S.B and Surana S.J., Spectrophotometric Method for Simultaneous Estimation of Levofloxacin and Ornidazole in Tablet Dosage forms, Indian Drugs,2006,43(10),803-806.
ICH, Guidelines for Validation of Analytical Methods, centre for drug evaluation and research, Procedures, 1996.
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