Abstract
A simple and precise and accurate RP - High-performance liquid chromatography (Reverse Phase - HPLC) method has been developed for the estimation of Ropinirole in tablet formulations. The separation was achieved on a C18(250 x 4.6 mm) 5 - micron Hypersil BDS using a mobile phase consisting of a degassed mixture of 0.05 M glacial acetic acid (2.85 mL of glacial acetic acid in 1000 mL of water) and acetonitrile (50:50) with a flow rate of 1.0 mL/min. The mobile phase showed the most favorable chromatographic parameter for analysis. The detection of the constituent was done using UV detector at 250 nm. The retention time of ropinirole was found to be 3.987 minutes. The method was validated for system suitability, precision, accuracy, linearity, robustness. The linear range for ropinirole was 4 12 g / ml. The method is validated for accuracy, precision, linearity, specificity and robustness in accordance with ICH guidelines and revealed that the method established specific, accurate, rapid, precise, reliable and reproducible for the method has been successfully used to analyze commercial solid dosage forms which are locally available 0.25 mg ropinirole tablets and its percentage recovery was found to be 99.82%.
Highlights
Ropinirole (RPR) is a non-ergoline dopamine agonist, chemically it is 4-[2-(dipropylamino) ethyl] -1, 3-dihydro-2H-indol-2-one monoHCL, is a specific D2 and D3 receptor non-ergoline dopamine agonist that is probably effective as L-dopa in mild, early Parkinson’s disease[1 ]
Individual drug solution of 20 mcL was injected into the column at ambient temperature at a concentration of 10 ppm and it was chromatographed for 8 min using mobile phase at a flow rate of 1.0 mL/min and the UV spectra of ropinirole was recorded at a wavelength of 250 nm
System repeatability was determined by ten replicate injections of a standard solution, the relative standard deviation (RSD) of retention time and peak area of ropinirole was less than 2.0 %. 3.3 Detection and Quantitation limit: Detection and Quantitation limit were calculated by the method based on the standard deviation (σ) and slope (S) of the calibration plot, using the formulae LOD = 3.3 σ/ S and LOQ = 10 σ/ S. and were mentioned in table no.1 3.4 Specificity of Ropinirole: Specificity was assessed by comparison of chromatograms obtained from tablets and blank solution and from the drug standards
Summary
Ropinirole (RPR) is a non-ergoline dopamine agonist, chemically it is 4-[2-(dipropylamino) ethyl] -1, 3-dihydro-2H-indol-2-one monoHCL, is a specific D2 and D3 receptor non-ergoline dopamine agonist that is probably effective as L-dopa in mild, early Parkinson’s disease[1 ]. Very few high-performance liquid chromatographic (HPLC) methods in plasma were developed using ultraviolet2,3 , electrochemical 4 or mass spectrometric 5 detection. Capillary zone electrophoresis was used for the determination of the dissociation constants of RPR. It is not official in any pharmacopoeia. Spectrophotometric, Spectroflourimetric methods 7-10 have been reported for the estimation of RPR in dosage forms and in human plasma, but these methods are costly and require sophisticated equipments for the processing of drug. The present study is designed to develop a simple, precise and accurate reverse phase HPLC method with good recoveries and shorter retention time for the estimation of Ropinirole in the tablet formulations
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