Abstract
Objective: To develop and validate stability indicating HPTLC method for determination of clevidipine butyrate in synthetic mixture.Methods: The present study deals with development and validation of stability indicating HPTLC method for estimation of clevidipine butryate. Chromatographic separation was performed on aluminum plate pre coated with Silica Gel 60 F254 using toluene: ethyl acetate (8:2) as mobile phase. TLC scanner was set at wavelength of 370 nm.Results: Retention factor Rf of clevidipine was found to be 0.49. The method was validated as per ICH guidelines. Calibration curve was in the range of 1000-6000ng/band. The correlation coefficient was found to be 0.999. The precision expressed by RSD was less than 2%. The accuracy of method was confirmed by recovery studies using standard addition method and recovery was found to be 99.03-99.57%. The drug was subjected to ICH prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. Clevidipine and its degradation products were well resolved under experimental conditions. The method was validated according to ICH guidelines. The drug showed significant degradation in alkaline and acidic condition and slight degradation in oxidative condition. The drug was stable in thermal condition.Conclusion: A new, Simple, Accurate, Precise, Sensitive and economic stability indicating HPTLC method has been developed and validated for the determination of clevidipine and can be employed for stability indicating analysis.
Highlights
Clevidipine butyrate (CLEVI) is dihydropyridine L-type calcium channel blocker that is selective for vascular smooth muscle [1]
Mobile phase toluene: ethyl acetate in a ratio of 8:2 was found to give sharp well defined peak at Rf value of 0.49±0.0057 for CLEVI which is shown in fig
HPTLC method has an advantage over HPLC methods in the form that the reported HPLC methods [9], method is developed by gradient method which is timeconsuming and method [10, 11] is isocratic with longer retention time while in hptlc method standard and sample can be analysed simultaneously on same TLC plate
Summary
Clevidipine butyrate (CLEVI) is dihydropyridine L-type calcium channel blocker that is selective for vascular smooth muscle [1]. It is indicated for reduction of blood pressure when oral therapy is not possible [2]. It is available as lipid emulsion for intravenous infusion and is approved in US. It is marketed as Cleviprex by The Medicines Company [3]. Various methods are reported for determination of related substances of clevidipine butyrate by HPLC method [9,10,11]
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