Stability indicating method

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.

The study describes the simple, sensitive, accurate, rapid and reliable ultra violet spectroscopic method has been developed for determination of Deferiprone in bulk drug and pharmaceutical formulation. Deferiprone is use as second line agent for thalassemia when iron overload from blood transfusion occurs.in order to investigate the stability of drug, a stress testing of drug sample by exposing it to variety of force degradation conditions has been recommended. Deferiprone was subjected to stress degradation under different condition recommended by international conference on harmonization (ICH). Deferiprone shows maximum absorbance at 279nm & calibration graph linear in the concentration range 5-25 Mcg/ml with correlation co-efficient 0.9997.The higher percentage of recovery study indicates that there is no interference of excipients in the presence of formulation. The stability study indicates appreciable changes were observed by treating the drug with acidic hydrolysis, basic hydrolysis and oxidation. However, there is no appreciable changes were observed for thermal stress and photolytic degradation.