STABILITY INDICATING METHOD OF CARBIDOPA AND LEVODOPA ASSAY IN CARBIDOPA, LEVODOPA AND ENTACAPONE FILM COATED TABLETS BY RP- HPLC
AbstractABSTRACT: The present work describes high sensitive and reproducible method of Carbidopa and Levodopa assay in Carbidopa, Entacapone and Levodopa film coated tablet. It was developed by usingkromosil C18, 125mm × 4.0mm × 5µm column, mobile phase (A) phosphate buffer pH 3.8 and, mobile phase (B) methanol and water with gradient method. Retention time of carbidopa and levodopa is 3.83 and 1.80 minutes respectively. It was evaluated for identification and quantification by using high performance liquid chromatography their separation being dependent on the pH of mobile phase. Critical resolutions between carbidopa and 3-Methoxy DL-Tyrosine (Levodopa impurity) and Levodopa impurity and Levodopa in assay method, it has been validated according to ICH Guidelines. Precision study was obtained results average of 12 sample % RSD Carbidopa 0.88 and Levodopa 0.71. And linearity was found to be (Carbidopa R2 = 0.9991 and Levodopa 0.9990). Recovery was found to be (97% to 103%). Robustness, solution stability and degradation impurities are determined by this method. Based on validation results, it is a stability indicating method.
Article Information
61
5530-5553
617KB
4600
English
IJPSR
Naresh Konduru and G.V. Madhuri *
Assistant Professor, Department of chemistry, Gitam university, Hyderabad campus, Rudraram Medak, A.P- 502329, India.
madhuri@gitam.edu
09 April, 2014
18 June, 2014
23 November, 2014
http://dx.doi.org/10.13040/IJPSR.0975-8232.5(12).5530-38
01 December 2014
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