DOI: 10.21276/ajptr
Fri, 17 Aug 2018

Stability Indicating HPTLC Method for Determination of Eletriptan Hydrobromide

MrinaliniChintamaniDamle1*, Supriya Shankarrao Darandale1

1.Department of Quality Assurance, A.I.S.S.M.S. College of Pharmacy, Kennedy Road, Near R.T.O., Pune-411001, Maharashtra, India.


ABSTRACT

Eletriptan hydrobromide is used for the acute treatment of attacks of migraine with or without aura in adults. It is also used in Vascular Headaches. To develop stability indicating method, the technique of forced degradation studies was adopted. Eletriptan hydrobromide solution was spotted on plates precoated silica gel 60F254. The mobile phase used was Methanol: Toluene (9.5: 0.5 v/v) and quantification was carried out at wavelength225 nm. The system showed a peak for Eletriptan hydrobromide at Rf value of 0.23 ± 0.03.The Drug was subjected to acid, base, neutral hydrolysis, oxidation, thermal degradation and photolysis. Stress testing of Eletriptan hydrobromide was carried out according to the International Conference of Harmonization (ICH) guideline Q1A (R2).The method was successfully validated according to ICH guidelines Q2 (R1). The data of linear regression analysis indicated a good linear relationship over the range of 500–2500 ng/band concentrations with correlation coefficient value of 0.9979. The accuracy of the method was established based on the recovery studies. The LOD and LOQ of Eletriptan hydrobromide was found to be 31.03 ng/band and 94.06 ng/band respectively. Among various stress conditions, Eletriptan hydrobromide showed considerable degradation under alkali and acid catalyzed hydrolysis, oxidative and photolytic condition.

Keywords: Eletriptan Hydrobromide, High Performance Thin Layer Chromatography, Stability indicating method, Forced Degradation.


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