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Development and validation of a dissolution test with Reversed-Phase Liquid Chromatography analysis for Ropinirole in tablet dosage forms

Author(s): Sundaramurthy Poongothai1*, Varadarajan Balaji2, Rajasekhar reddy 2, Petla Y Naidu 2, Raju Ilavarasan3, Chandrakantham M Karrunakaran1

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 5;
Start page: 1524;
Date: 2011;
Original page

Keywords: In vitro release | Stability | Ropinirole HCl | RP-HPLC | LC-MS/MS | Validation.

A dissolution test for in vitro evaluation of tablet dosage forms containing 5 mg of ropinirole was developed and validated by reverse phase high performance liquid chromatography. A discriminatory dissolution method was established using apparatus basket at a stirring rate of 50 rpm with 500 mL of pH 4.0 deaerated citratebuffer as dissolution medium and detection was carried out at 250 nm. The retention time of ropinirole hydrochloride was found to be 3.84 minutes. The proposed method was validated to meet requirements for a global regulatory filing which includes linearity, specificity, precision, accuracy, ruggedness and robustness and to evaluate the formulation during an accelerated stability study. The method can be applied for the quality-control analysis of ropinirole tablets. Moreover, quantitative analysis was also performed, to compare the applicability of the RP-LC and the LC-MS/MS methods.
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