Development and Validation of a Robust and Efficient HPLC Method for the Simultaneous Quantification of Levodopa, Carbidopa, Benserazide and Entacapone in Complex Matrices.

摘要: Purpose: A variety of fixed-dose combination products is used in the therapy Parkinson Disease. However, to date a proper analytical method applicable for comparative screening different antiparkinson was not available. The objective present work thus develop and validate an simultaneous quantification levodopa, carbidopa, benserazide entacapone. should be quantifying samples from drug release experiments with marketed prototype formulations performed under compendial biorelevant test conditions. Methods: fast robust separation four compounds developed validated according International Conference on Harmonization guidelines. Method validation covered applicability wide concentration range all peak complex sample matrices such as dissolution media. Results: were successfully separated by using gradient elution endcapped LiChrospher 100 RP-18 (250 x 4.6 mm, 5 µm) column coupled precolumn (4 4 at temperature 35.0 °C flow rate 1.50 mL/min. injection volume 30 µL detection wavelengths 280 210 nm, respectively. For drug/media combinations linear (r2 > 0.999) corresponding 1.25 - 125 % label claim (i.e. 200 mg levodopa/entacapone 50 carbidopa/benserazide) released. All other parameters specified limits over same range. Conclusion: new allows entacapone without any interference caused excipients or ingredients media presents valuable tool both formulation development vitro numerous drugs. This article open POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment clicking ABSTRACT issue’s contents page.