High Performance Thin Layer Chromatography

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.

A simple, sensitive and accurate method employing HPTLC has been developed and validated as per ICH guidelines for determination of Bosentan in bulk and Tablet dosage form. The absorption maxima of the drug were found to be 288 nm in methanol. The method was validated as per ICH guidelines. The linearity range was found to be 50-300 ng/ml with a regression coefficient of 0.98.Subsequent validation parameters like precision, repeatability in terms of Interday and Intraday precision and recovery studies were evaluated with satisfactory results, the % RSD for these parameters was found to be 1.73%,1.30-0.48%,1.80 – 0.45 % , 1.54 – 1.48 % respectively with an Rf value of 0.23.