Validated Method for Simultaneous Estimation of Ofloxacin and Satranidazole in Dosage Forms by Rp-Hplc

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  • Topic: Chromatography, Dosage form, High performance liquid chromatography
  • Pages : 19 (2891 words )
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  • Published : January 26, 2013
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Sureshbabu Bysani*, Nageshkumar Mutyala, Anilkumar Voodikala, Nataraj Kalakonda, Srinivasa Rao Atla
Department of Pharmaceutical Analysis & Quality Assurance, Shri Vishnu College of Pharmacy, Vishnupur, Bhimavaram-534202, West Godavari – D.T., Andhra Pradesh, India.
A simple, sensitive, and precise RP-HPLC method for the simultaneous estimation of Ofloxacin (OFL) and Satranidazole (SAT) combined dosage form has been developed and validated. The components were well separated using THERMO HYPERSIL BDS C18 (4.6 mm id, 250 mm, 5 µm) column using acetonitrile: 5% of orthophosphoric acid in water (40:60% v/v) as mobile phase at a flow rate of 1.0 mL/min. The eluents were detected at 295 nm using PDA detector. The retention times of OFL and SAT were found to be 2.8 and 3.8 min respectively. The linearity was observed in the range of 100 - 300 µg/mL for OFL and 150 - 450 µg/mL for SAT. The marketed dosage form was analyzed by using the developed method and the percent content of OFL and SAT were found to be 99.33±0.83 and 98.36±0.60. The developed method was validated for parameters like system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits. The validated method was used for the stability studies (short, long and auto sampler) and forced degradation studies (acidic, alkaline, oxidative and photolytic). Both OFL and SAT were found to be stable in all conditions. This validated method can be used for the routine quality control testing of OFL and SAT combined dosage form.

Keywords Ofloxacin, Satranidazole.
Chemically, an anti bacterial drug Ofloxacin (OFL) is 9-fluoro-2, 3-dihydro-3methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-Pyrido [1, 2, 3-de]-1, 4benzoxacine-6-carboxylic acid] 1 (Fig. 1). OFL inhibit the DNA gyrase enzyme2. Chemically, anti helmenthic drug Satranidazole (SAT) is 1-(1-Methyl5-nitro-1H-imidazol-2-yl)-3-(methylsulfonyl)-2-imidazolidinone (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-[(2R,4R)tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]-1-napthyl-2,2-dimethylbutanoate3

(Fig. 2). It is frequently prescribed drug used to treat Ameobiosis2. OFL is official in IP, BP and USP whereas SAT is not. Several methods have been reported for the assay of OFL, SAT in bulk, dosage forms with other drug combinations like HPLC4-10, HPTLC11, LC-MS/MS12 and UV-Visible spectrophotometry13-14. The literature review revealed that there are many chromatographic methods available for the simultaneous estimation of this combination. Hence an attempt was made to develop a validated analytical method for the simultaneous estimation of OFL and SAT combined dosage form using RP-HPLC method to bring out eluents at lower retention times and lower consumption of solvents.

Fig. 1: Structure of OFL

Fig. 2: Structure of SAT

Chemicals and Reagents
HPLC grade methanol, acetonitrile and all other analytical grade reagents were purchased from Merck, India. HPLC grade water was prepared using Milli-Q water purification system. Satrogyl-O tablets were purchased from local markets of Hyderabad. Class A glassware is used throughout the experiment. OFL and SAT gift samples were obtained from Alkem Laboratories Ltd.

Equipment & Chromatographic conditions
The chromatographic system consists of a Shimadzu class VP Binary pump LC10ATvp Pump, SIL-10ADvp auto sampler, CTO-10Avp Column temperature oven, SPD-10Avp UV-Visible detector. All the components of the system are controlled using SCL-10Avp system controller. Data acquisition was done using LC Solutions version 1.23software. Chromatographic separations were carried out using THERMO HYPERSIL BDS C18 (4.6 mm id, 250 mm, 5 µm) reverse phase column with a mobile phase consisting of acetonitrile...
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