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Research Article Analytical Method Development and Validation Of Scholars Academic Journal of Pharmacy (SAJP) ISSN 2320-4206 (Online) Sch. Acad. J. Pharm., 2015; 4(9): 398-404 ISSN 2347-9531 (Print) ©Scholars Academic and Scientific Publisher (An International Publisher for Academic and Scientific Resources) www.saspublisher.com Research Article Analytical method development and validation of diloxanide furoate and ornidazole in its combined pharmaceutical dosage form Hemangi Vaidya, Sweetu Patel, Divya Patel, Prasanna K Pradhan*, Umesh Upadhyay Sigma Institute of Pharmacy, Timbi, Gujarat 391760, India *Corresponding author Prasanna Pradhan Email: [email protected] Abstract: A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Diloxanide Furoate and Ornidazole in Their Combined Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Buffer (pH 4.5): Acetonitrile (40:60) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 277 nm. Retention time of Ornidazole and Diloxanide Furoate were found to be 4.620 min and 7.633 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Ornidazole 5-15 μg/ml and for Diloxanide Furoate 7.5-22.5 μg/ml. The percentage recoveries obtained for Ornidazole and Diloxanide Furoate were found to be in range of 100.88 ± 0.60 and 100.85± 0.20 respectively. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial combined dosage form. Keywords: Ornidazole (ORN), Diloxanide Furoate (DIF), Stability indicating RP-HPLC Method, Validation. INTRODUCTION Statistically designed experiments were performed by The number of drugs introduced into the varying different method parameters such as buffer market is increasing every year [1]. DIF: DIF is an anti- concentration, pH of mobile phase, flow rate, mobile protozoal drug used in the treatment of Entamoeba phase composition, and column temperature, to study histolytica and some other protozoal infections. DIF is the effect of these method parameters on system used alone as a primary agent in the treatment of suitability criteria of all two drugs as a part of the asymptomatic (cyst passers) intestinal amoebiasis robustness study. caused by Entamoeba histolytica this medication may also be used concurrently, or sequentially, with other EXPERIMENTAL: agents such as the nitroimidazoles in the treatment of Materials and Reagents: invasive or extra intestinal forms of amoebiasis. DIF Pure ORN and DIF were obtained as gratis alone is not effective in the treatment of invasive or sample from Alembic pharmaceuticals (Baroda, India). extra intestinal amoebiasis [2]. ORN: ORN is a Acetonitrile, potassium hydrogen phosphate, methanol nitroimidazoles antiprotozoal agent used in amoeba and were purchased from Samir tech chem (Baroda, trichomonas infections. It is partially plasma-bound and India).All reagents used were at least of analytical grade also has radiation sensitizing action. ORN is primarily except acetonitrile, methanol, water which was HPLC indicated in conditions like Amoebiasis, Amoebic grade. High purity water was prepared by passage dysentery, Bacterial vaginosis, Giardiasis, through a samir tech chem. (Baroda, India) and was Trichomoniasis. Plasma half life is 12-14 hrs[3]. used to prepare all solutions. Several HPLC methods are available in the Preparation of Standard Solutions: [4, 5] literature for individual drugs and for a combination (A) ORN standard stock solution: (100 μg/mL) A 10 with other drugs for determination of ORN and DIF, but mg of ORN was weighed and transferred to a 100 mL no stability-indicting assay method (SIAM) has been volumetric flask. Volume was made up to the mark with reported. Accordingly, the present study was planned to methanol. develop stability-indicating assay RP-HPLC method for (B) DIF standard stock solution: (150 μg/mL) A 15 mg the simultaneous determination of ORN and DIF in of DIF was weighed and transferred to a 100 mL presence of interaction/degradation product. The volumetric flask. method was validated with respect to linearity, (C) Preparation of standard solution of binary mixtures precision, accuracy, specificity, and robustness. of ORN (10 μg/mL) and DIF (15 μg/mL) 1 mL from the 398 Hemangi Vaidya et al., Sch. Acad. J. Pharm., December 2015; 4(9):398-404 ORN stock solution and 1mL from DIF stock solution by sonication in all HPLC runs. The injection volume and transferred to 10 mL volumetric flask and volume was 20μL and a mixture of mobile phase A and B made up to the mark by mobile phase which was used (40:60v/v) was taken as diluent. The column used for in particular trials. the entire study was hypersil BDS (25cm × 4.6 mm i.d., particle size 5μm). HPLC Instrumentation & Chromatographic Conditions: Method Validation [10, 11] The analysis was carried out on a HPLC The method was validated for linearity, system (shimadzu) equipped with U.V detector. Other precision (interday, intraday, and repeatability), apparatus and instruments used were a micro analytical accuracy, and robustness as per the ICH guideline Q2 balance (shimadzu, type-BL-22OH), Ultra sonicator (R1). Precision: Results should be expressed as Relative (EIE instruments), pH meter (welltronixPM100).All standard deviation (RSD) or coefficient of variance. A. instruments and glassware’s were calibrated. Repeatability: Standard solution containing ORN Chromatographic analysis was carried out on an (10μg/ml) and DIF (15 μg/ml) was injected six times Hypersil BDS C-18 column,(25cm× 0.46cm).The and areas of peaks were measured and % R.S.D. was mobile phase consisted of Buffer(pH 4.5):Acetonitrile calculated. B. Intra-day precision Standard solution (40:60).The mobile phase was filtered through containing (5, 10, 15 μg/ml) of ORN and (7.5,15,22.5 Millipore filter paper type HV (0.45 µm) and degassed μg/ml) of DIF were analyzed on the same day in by sonication, was pumped at 1 ml/min flow rate. The triplicate and Inter-day precision were analyzed three column was thermo stated at room temperature. Under times on the different day and % R.S.D was calculated these conditions the run time was 9 min. of both .The accuracy was determined by spiking the mixture of stressed samples with three concentration of Forced Degradation Study: [6, 7] drug corresponding to 80%, 100%, and 120% of ORN (A) Acid degradation: One ml of stock solution was and DIF (80μg/mL, 100μg/mL, 120μg/mL) in transferred in to 10 ml of volumetric flask. Two ml of combination in triplicate. The mean percentage 0.1 N HCl solutions was added and mixed well and put recoveries for the proposed method were calculated for 4 hrs at 70 ºC. After time period the content was then determining percent recovery of the added drug. cooled to RT. Then the volume was adjusted with LOD and LOQ were determined from the set of 3 diluents to get 10μg/ml for ORN and 15 μg/ml for DIF. calibration curves used to determination method (B) Base degradation: One ml of stock solution was linearity. transferred in to 10 ml of volumetric flask. Two ml of 0.1 N NaOH solutions was added and mixed well and Robustness Experiments: put for 3 hrs at 70 ºC. After time period the content was Robustness of the method was checked by cooled to RT. Then the volume was adjusted with deliberate changes in the chromatographic conditions diluents to get 10μg/ml for ORN and 15 μg/ml for DIF. ratio of Mobile phase was changed (±2) Buffer: (C) Oxidative degradation: One ml of stock solution Acetonitrile (38:62) and Buffer: Acetonitrile (42:58), was transferred in to 10 ml of volumetric flask. Two ml flow rate (0.3 and 1.2mL/min), pH (4.3 and 4.7), of 3% H2O2 solutions was added and mixed well and gradient flow (in composition), and column temperature put for 30 min at 70 ºC. After time period the content (25°C and 30°C). was cooled to RT. Then the volume was adjusted with diluents to get 10μg/ml for ORN and 15 μg/ml for DIF. RESULTS AND DISCUSSION: (D) Photo Degradation: One ml of stock solution was Development and Optimization of the Stability- transferred in to 10 ml of volumetric flask. The Indicating HPLC Method: volumetric flask was kept in Sunlight for 1 hrs. Then The literature search indicated that many the volume was adjusted with diluents to get 10μg/ml HPLC methods were available for individual and a for ORN and 15 μg/ml ford IF. combination of two drugs. Based on the literature (E) Thermal degradation: One ml of stock solution was search, attempts were made to develop a simple method transferred in to 10 ml of volumetric flask. The which had less retention time and higher selectivity. But volumetric flask was stored in oven at 105°C for 5 hrs. Reverse phase chromatography was chosen because of Then the volume was adjusted with diluents to get its recommended use for ionic and moderate to non- 10μg/ml for ORN and 15 μg/ml for DIF. polar compounds. Reverse phase chromatography is not only simple, convenient but also better performing in Separation Studies and Development of Stability- terms of efficiency, stability and reproducibility. C18 Indicating Method: [8, 9] column is least polar compare to C4 and C8 columns. Satisfactory separations were achieved by Here, A 250 x 4.6 mm column of 5.0 μm particle gradient elution using mobile phase of different packing was selected for separation of ORN and DIF. composition of Buffer (pH 4.5): Acetonitrile (40:60) at Isocratic mode was chosen due to simplicity in a flow of 1.0mL/min.
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