Manjula, (2018) Simultaneous Determination and Validation of Ofloxacin and Ornidazole in Combined Dosage Pharmaceutical Formulation by RP-HPLC Method. Masters thesis, J.K.K.Munirajah College of Pharmacy, Komarapalayam.
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Abstract
Ornidazole is a 5-nitroimidazole derivative and is used in the treatment of susceptible protozoal infections and also in anaerobic bacterial infections. It has been used for amebic liver abscesses, duodenal ulcers, giardiasis, intestinal lambliasis and vaginitis. Ornidazole has recently been used with success in patients with active Crohn’s disease. It is more effective against amebiasis than metronidazole, which is the most commonly used nitroimidazole derivative in therapy12- 14. Ornidazole has also been preferred for surgical prophylaxis because of its longer elimination half-life and excellent penetration into lipidic tissues versus other nitroimidazole derivatives. Ornidazole is used in combination with Ofloxacine in the tretment of PLD and in intra-abdominal infection. In this present communication we reports two simple, accurate, and most economical methods for simultaneous estimation of ornidazole and ofloxacin in combained dosage forms. Fixed dose combination of Ornidazole 500 mg and Ofloxacin 200 mg is available in the tablets form in the market. The present work describes a simple, precise and accurate reversed phase HPLC method for the simultaneous estimation of Ornidazole and Ofloxacin in combined dosage form. The method was validated according to procedures and acceptance criteria based on FDA guidelines and recommendations of ICH. A HPLC for Ofloxacin and Ornidazole was developed and validated in combined tablet dosage form as pre ICH Guide lines UV Detector and Agilent C 18 (250x4.6mm) 5μ column, injection of 20μl is injected and eluted with the mobile phase of Potassium dihydrogen phosphate buffer with pH3.5: (Acetonitrile & Tetra hydro furan35:1 v/v) in the ratio 64.9:35 which was pumped at a flow rate of 1.0ml at 300nm. The peak of Within limits was found well separated within 8min. The developed method was validated for various parameters as per ICH guidelines like system suitability, specificity, linearity, system precision, method precision, accuracy, ruggedness and robustness. The analytical method validation of Ofloxacin and Ornidazole by RP-HPLC was found to be satisfactory and could be used for the routine pharmaceutical analysis of Ofloxacin and Ornidazole.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg. No. 261630703 |
| Uncontrolled Keywords: | Simultaneous Determination ; Validation ; Ofloxacin ; Ornidazole ; Combined Dosage Pharmaceutical Formulation ; RP-HPLC Method. |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Subramani R |
| Date Deposited: | 30 Jun 2019 13:58 |
| Last Modified: | 30 Jun 2019 13:58 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/10675 |
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