Abstract
With the objective of developing an advanced method for rapid separation with shorter runtime, a simple, precise, and accurate stability-indicating isocratic RP-LC method coupled with PDA detector was developed for the quantitative determination of flupirtine maleate in bulk and in capsule dosage form. Good resolution between the peaks for degradation products and the analyte was achieved on a Waters Agilent XDB C18 ( mm, 5 μm) column using mobile phase containing a mixture of phosphate buffer pH 3.36 and acetonitrile in the ratio of 65 : 35. The eluted compounds were monitored at 344 nm and the flow rate employed for the present investigation was 1 mL/min. The newly developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness. The method may be employed for the assay determination of flupirtine maleate in pharmaceutical dosage forms.
Highlights
Flupirtine maleate is a nonopioid centrally acting, structurally dissimilar from other analgesics
Jakob and Krieglstein found an activation of G protein-regulated inwardly rectifying K+ channels (GIRKs) by flupirtine in therapeutically relevant concentration ranges [2]
For HPLC study, the resultant solution was diluted to 100 μg/mL solution and 10 μL was injected into the system and the chromatograms were recorded to assess the stability of the sample
Summary
Flupirtine maleate is a nonopioid centrally acting, structurally dissimilar from other analgesics. Jakob and Krieglstein found an activation of G protein-regulated inwardly rectifying K+ channels (GIRKs) by flupirtine in therapeutically relevant concentration ranges [2]. The opening of these channels inhibits exaggerated neuronal action potential generation and controls neuronal excitability [3]. Till no stability-indicating analytical method for the determination of flupirtine maleate was found by computer assisted literature survey. The ultimate aim of the present investigation was to develop a simple, precise, and stability-indicating HPLC method which resolves all the degradation products formed during the stress degradation studies and to validate the method according. The optimization of the method separation, stability-indicating property, evaluation, and quantification of flupirtine maleate are reported
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