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Rp-Hplc Method Development and Validation for Simultaneous Quantitative Estimation of Diloxanide Furoate and Ornidazole in Tablets

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Rp-Hplc Method Development and Validation for Simultaneous Quantitative Estimation of Diloxanide Furoate and Ornidazole in Tablets Innovare International Journal of Pharmacy and Pharmaceutical Sciences Academic Sciences ISSN- 0975-1491 Vol 7, Issue 2, 2015 Original Article RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS QUANTITATIVE ESTIMATION OF DILOXANIDE FUROATE AND ORNIDAZOLE IN TABLETS P. SIVAPRASAD1, S. YASWANTH KUMAR1, A. ASHOK KUMAR2* 1Chandra Labs, 5-5-35/173, Plot No-10, 1st Floor, IDA Prasanthi Nagar, Kukatpally, Hyderabad, India 500090, 2Department of Pharmaceutical analysis and Quality Assurance, Vijaya college of pharmacy, Munaganur (village), Hayathnagar (mandal), Hyderabad 501511, India. Email: [email protected] Received: 16 Oct 2014 Revised and Accepted: 08 Nov 2014 ABSTRACT Objective: To develop an accurate, precise and linear Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in tablets and validate as per ICH guidelines. Methods: The optimized method uses a reverse phase C18 column, ZODIAC (250 X 4.6 mm; 5 ), mobile phase consisting of mixed phosphate buffer (KH2PO4 and K2HPO 4): acetonitrile in the proportion of 30:70 v/v. The mobile phase was set at a flow rate of 1.0 ml/min and the volume injected 9 nm. μ wasResult 20μls: Thefor every developed injection. method The detection resulted wavelengthin Diloxanide was furoate set at 27eluting at 4.293 min and Ornidazole at 3.34 min. Diloxanide furoate exhibited - - deviations of 0.97% for Diloxanide furoate and 0.3% for Ornidazole. Percentage Mean recoveries were found to be in the range of 98-102, during linearity in the range The 90 limit210μg/ml, of detection while (LOD) Ornidazole for Diloxanide exhibited furoate linearity and in Ornidazole the range 60were140μg/ml. found to Thebe 8.80 precisionµg/ml isand exemplified 6.68µ by relative standard limit of quantitiation (LOQ) for Diloxanide furoate and Ornidazole were found to be 26.6µg/ml and 20.25µ accuracy studies. g/ml respectively, while Conclusion: A simple, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneousg/ml quantitative respectively. estimation of Diloxanide furoate and Ornidazole in Amicline plus tablets and validated as per ICH guidelines. Hence it Diloxanide furoate and Ornidazole in tablets in various pharmaceutical industries. can be used for the routine analysis of Keywords: RP-HPLC, Diloxanide furoate, Ornidazole, Method development, Validation. INTRODUCTION Entameba histolytica [6 bowel lumen and is used in the treatment of the intestinal Ornidazole (Fig. -(3-chloro-2- -2- amoebiasis.passing cysts Diloxanide of furoate has been used]. It actsin the principally treatment inof the -5-nitroimidazole. It has a molecular formula of C 7H10ClN 3O3 Entameba histolytica [6] and is excellent 1) chemically is 1 hydroxypropyl) and a molecular weight of 219.625 g/mol. Ornidazole is a derivative 7-8]. methylof 5-nitro imidazole used as an anti-infective agent [1]. Ornidazole is asymptotic carriers of amoebicide for cyst passers [ O amine that binds to microbial DNA and prevents nucleic acid H C formation,converted belonginginto an active to class form of bacteriostaticby reduction [2]of . itsOrnidazole nitro group is used to 3 for the treatment of bacterial vaginosis, trichomoniasis, Cl N O O , amoebiasis, giardiasis. It is also used in infections against anaerobic bacteria and in the genitourinary infections in women and men Cl O cological operations [2]. treatment of prophylaxis during surgical interventions, particularly Fig. 2: Structure of Diloxanide furoate drugsthose involvingfor peptic theulcers, colon, few and in gynae , stomach cancers, rheumatoidOrnidazole has arthritis been [successfully3 employed in combination’s disease with other[4]. re exists literature on types of gastritis chromatographic methods for Ornidazole alone and in combination ] and in the prophylaxis of Crohn withA detailed other literature drugs [9survey-16] andreveals that theDiloxanide furoate in Cl combination with other drugs [17-22] in various matrices. While there is literature similarlyreported on RP-HPLC method development and validation for the simultaneous quantitative OH estimationhardly of Diloxanide any furoate and Ornidazole in pharmaceutical dosage forms. N O N CH 2 3 Hence we have explored in developing a new, accurate, precise, N linear and a rapid isocratic RP-HPLC method for the simultaneous quantitative estimation of Diloxanide furoate and Ornidazole in Fig. 1: Structure of Ornidazole Amicline plus tablets and validate as per ICH guidelines. MATERIALS AND METHODS Diloxanide furoate (fig. 2) 4-(N- -2, 2- Chemicals and reagents -2-furoate having the molecular formula as C14H11Cl2NO4 and the molecularchemically weight asis 328.147 methyl g/mol [5]. It dichloroacetamido)is an phenyl purities greater than 99% were obtained as gift samples from Analytically pure sample of Diloxanide furoate and Ornidazole with effective drug for the treatment of asymptotic persons who are Ashok et al. Int J Pharm Pharm Sci, Vol 7, Issue 2, 515-519 The detection wavelength was set at 279 nm. labelledChandra amountLabs, Hyderabad, 375mg and India 2 50mgand tabletof Diloxanide formulation furoate [Amicline and of 1.0 ml/min and the volume injected was 20μl for every injection. plus] was procured from Medplus pharmacy, Hyderabad, India with Buffer preparation 1.625 gm of (KH 2PO4) and Ornidazole respectively. Acetonitrile (HPLC2 POgrade)4) and was dipotassium obtained 0.3 gm 2HPO 4) was from Sigma aldricho phosphate (Hyderabad, (K 2HPO 4)India), (AR grade), water ortho (HPLC phosphoric grade), weighed and potassiumdissolved indihydrogen 100 ml of waterortho phosphateand volume was made up potassium dihydrogen ortho phosphate (KH to 1000 ofml dipotassiumwith water. Adjusthydrogen the pHortho to 6.0phosphate using ortho (K phosphoric India),hydrogen orth acid. The buffer was filtered through 0.45µ filters to remove all fine acid (AR Grade) were obtained from SD Fine chemicals (Hyderabad, particles and gases. 0.45μm Nylon membrane filters were obtained from SpincotechInstrument Private Limited, Hyderabad, India. Mobile phase preparation performed on Shimadzu LC-20AT VP Liquid Chromatograph comprising a LC-20AT pump, Shimadzu SPD-20A the ratio of 70:30 v/v and later it was sonicated for 10 minutes for UVHPLC-VISIBLE analysis detector was and a reverse phase C18 column, ZODIAC (250 theThe removal mobile phase of air bubbles.was prepared by mixing acetonitrile and buffer in X 4.6 mm; 5 ) sample loop was equipped with Diluent was controlledμ . withA manually “Spinchrom operating” software. Rheodyne A double injector beam with UV- visible20 μL Diluent used is the mobile phase itself. spectrophotometer Nicolet evolutionthe HPLC100 having system. two The matched HPLC systemquartz cells with 1 cm light path was used for recording of spectra and Preparation of stock and working standard solution for measuring absorbance. Diloxanide furoate BL220H), digital pH meter (Global digital) and sonicator (Citizen) An electronic analytical weighing balance (1mg 15mg of Diloxanide furoate was taken in 10 sensitivity, Shimadzu ml volumetric flask containing 8 ml of solvent and Method were used in this study. then the solution was made up toaccurately the mark weighedusing the and solvent . This is consideredclean and as drystandard stock solution (1500µg/ml). 1 ml of the Selection of wavelength stock solution was pipetted out and made up to 10 ml to get a concentration 150µg/ml, treated as working standard, 100% target recording UV spectrums in the range of 200-400 nm for individual concentration. drugSuitable solutions wavelength of Oforrnidazole the HPLC and analysisDiloxanide was furoate. determined Suita bleby wavelength selected for simultaneous estimation is 279 nm (Fig. 3-4). Preparation of stock and working standard solution for Ornidazole 10mg of Ornidazole 0 ml 0 ml of solvent and then the solution was madewas up accurately to the mark weighed using and the taken solvent in. 10This is consideredclean and dry as volumetricstandard stockflask containingsolution (1 8000µg/ml). 1 ml of the stock solution was pipetted out and made up to 10 ml to get a concentration 100µg/ml, treated as working standard, 100% target concentration. Preparation of stock and working sample solution 10tablets were weighed and taken into a mortar, crushed and then Ornidazole weightuniformly equivalent mixed. toTest 100 stock mg of solutions Ornidazole of and 150 mg of(1000μg/ml) Diloxanide andfuroate Diloxanide and made furoate up to (1500μg/ml)100 ml with mobilewere prepared phase. Sonicated by dissolving for 5 min and later filtered the solution using 0.45mi 1 ml of the above stock solution was pipetted out and made up to 10 Fig. 3: UV spectrum of standard Diloxanide furoate ml to get working sample solution equivalent tocron a concentration syringe filter. of 100µg/ml for Ornidazole and 150µg/ml for Diloxanide furoate. RESULTS AND DISCUSSION Method development A Reverse phase HPLC method was developed keeping in mind the . e. resolution factor (Rs) between peaks, (A), number of theoretical plates (N), runtimesystem suitabilityand the cost parameters effectiveness. i The optimized method developed resultedPeak in the Asymmetry elution of Ornidazole at 3.34 min and Diloxanide furoate at 4.293 min. Fig.5-6 represents chromatograms of blank solution and mixture of standard solutions The total run time is 8 minutes. are an integral part of method development and are used to ensure respectively.adequate performance System suitability tests Rt), number of theoretical
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