Stability Indicating Method Development and Validation for the Estimation of Rotigotine by RP-HPLC in Bulk and Pharmaceutical Dosage Form

摘要

The purpose of the investigation was to develop a new RP-HPLC Method for estimation of Rotigotine in pharmaceutical dosage forms. Chromatography was carried out on an BDS C-8 column (4.6 x 150mm, 5u particle size) with a isocratic mobile phase composed of 0.01 N Potassium dihydrogen Ortho phosphate (adjusted to pH 4.8 with OPA solution), Acetonitrile (45:55v/v) at a flow rate of 1 mL/min. The column temperature was maintained at 30°C and the detection was carried out using a PDA detector at 224 nm. Validation parameters such as system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), Stability of sample and standard stock solutions and robustness were studied as reported in the International Conference on Harmonization guidelines. The retention time for Rotigotine was 2.691 min. The percentage recoverie of Rotigotine was 100.33%. The relative standard deviation for assay of patch was found to be less than 2%. The Method was fast, accurate, precise and sensitive hence it can be employed for routine quality control of patchs containing both drugs in quality control laboratories and pharmaceutical industries.