Abstract
Objective: A simple, economical, robust and stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the quantification of ropinirole hydrochloride in API and tablets to achieve shorter retention time, to minimize human error by avoiding the use of buffers and weighing procedure and analyze more number of samples in shorter period of time with good accuracy.
 Methods: The chromatographic conditions for separation of ropinirole hydrochloride was carried out using Gemini NX C18 column (15 cm x 4.6 mm), 5 µm particle size with the mobile phase composing of methanol: acetonitrile (70:30 v/v), delivered at flow rate 0.7 ml/min and UV detection wavelength at 250 nm.
 Results: The retention time was observed at 2.718 min. The system suitability results were found to be within limits. The method was precise, with lower than 2 %RSD and the calibration curve was linear (r2=1) over a concentration range of 2.5-160 µg/ml. The detection and quantification limit was found to be 0.045 µg/ml and 0.15 µg/ml, respectively. Recovery of the drug was found between 100.09-100.19%. The assay of ropinirole hydrochloride in ROPITOR® and ROPARK® tablets were found to be 100.4 and 103.60 %, respectively. The forced degradation studies were carried out to demonstrate the specificity of the method by exposing the API under conditions of hydrolysis, oxidation, thermal and photolytic as per ICH Q1A(R2) guidelines.
 Conclusion: The low coefficient of variation and agreeable recovery confirmed that the newly developed method could be employed for routine analysis of ropinirole hydrochloride in API and tablets.
Highlights
Ropinirole hydrochloride (RH) is the hydrochloride salt form of ropinirole, a non-ergot dopamine agonist with antiparkinson property [1], acting as a substitute for dopamine, ropinirole acts as a D2, D3 and D4 dopamine receptor agonist with more affinity for D2
The RP-HPLC analytical method developed consists of a mobile phase phosphate buffer and acetonitrile (50:50 v/v), at a flow rate 0.5 ml/min stationary phase using C18 column 250 x 4.6 mm, 5 μm particle size in isocratic mode and the total run time was 15 min achieved the retention time of 4.867 min [8]
RP-HPLC method developed with mobile phase comprising of acetate buffer (0.05 mol glacial acetic acid, pH 3):acetonitrile in the ratio of 50:50 v/v, at a flow rate 1 ml/min using the column C18 Hypersil BDS (250 x 4.6 mm, 5 μm) at 250 nm, the analyte elutes at retention time of 4.037 min and running time is 14 min [7]
Summary
Ropinirole hydrochloride (RH) is the hydrochloride salt form of ropinirole, a non-ergot dopamine agonist with antiparkinson property [1], acting as a substitute for dopamine, ropinirole acts as a D2, D3 and D4 dopamine receptor agonist with more affinity for D2. It is weakly active at the 5-HT2, and α2 receptors [2]. The pKa and water solubility was found to be 10.17 and 133 mg/ml [3] It is available in both conventional and extended-release tablet dosage form in the dose range from 0.25 mg up to 6 mg [4]. It is prescribed for the treatment of parkinson’s disease and restless legs syndrome [5]
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