A RP-HPLC Method Development and Validation of Tinidazole and Diloxanide Furoate in Pharmaceutical Formulation and its Forced Degradation Studies

Karnan, P (2017) A RP-HPLC Method Development and Validation of Tinidazole and Diloxanide Furoate in Pharmaceutical Formulation and its Forced Degradation Studies. Masters thesis, J.K.K. Nattraja College of Pharmacy, Kumarapalayam.

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Abstract

OBJECTIVE:According to literature survey, various analytical methods like UV, HPLC, etc. were reported for the simultaneous analysis of Tinidazole and Diloxaide Furoate. Stability indicating method studies were not available as per the existing literature survey. Hence studies were under taken to develop and validate stability indicating assay for estimation of these two drugs. It is felt worthwhile to develop a simple, rapid, accurate, precise and more economical stability indicating high performance liquid chromatographic method for Tinidazole and Diloxanide Furoate combination in bulk and its combined dosage form. Some RP-HPLC methods were not economical in terms of mobile phase composition, column dimensions and run times. Hence there is need for the development of newer method for estimation of Tinidazole and Diloxanide Furoate present in tablet to overcome above discussed hurdles. Develop and validate the stability indicating assay method for Tinidazole and Diloxanide Furoate using RP-HPLC technique: Hence the present work is aimed to develop and validate the stability indicating assay method for Tinidazole and Diloxanide Furoate using RP-HPLC technique. The Present study was planned to develop a faster gradient elution for estimation of Tinidazole and Diloxanide Furoate. The developed method was planned to validate as per ICH and USP guide lines in terms of accuracy, precision, specificity, and limit of detection, limit of quantitation, linearity, range robustness. PLAN OF WORK: Study of physicochemical properties of the drug.Review of literature. Procurement of drug substances and related substances for study. Determination of isobestic point of Tinidazole and Diloxanide Furoate.  Selection of chromatographic conditions like column,mobile phase, and flow rate in RP-HPLC. Optimization of the method. Validation of the developed method as per ICH guidelines and conduct forced degradation studies.

Item Type: Thesis (Masters)
Uncontrolled Keywords: RP-HPLC Method ; Tinidazole ; Diloxanide Furoate
Subjects: PHARMACY > Pharmaceutical Analysis
Depositing User: Ravindran C
Date Deposited: 20 Dec 2017 11:59
Last Modified: 20 Dec 2017 12:08
URI: http://repository-tnmgrmu.ac.in/id/eprint/4590

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