In-vitro comparative degradation study of different brands of Flunarizine dihydrochloride tablet using UV Spectrophotometer

Abstract

The objective of this study was to develop the degradation studies of different brands of Flunarizine dihydrochloride tablet available in market. Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Flunarizine dihydrochloride is a calcium channel blocker which reduces arterial and arteriolar smooth muscle spasm by reducing intracellular Caoverload due to brain hypoxia. It is widely used in cerebral and peripheral vascular disorders and also as antihistaminic & sedative. This drug was subjected to different stress conditions as per International Conference on Harmonization guidelines (ICH). An ultraviolet UV spectroscopic method was developed for analysis of the drug in the presence of the degradation products. Ethanol was used as a solvent. The amount of degraded drugs was calculated by taking the absorbance at 253 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. In case of acidic pH and basic pH except Fluver amd Minium other brands were degraded. In addition to heat exposure only brand Norium was Stable. It was concluded that all brands werent degraded from ranges for all the stresses applied for degradation studies.