ISSN: 2249-9504

Development and validation of Stability Indicating RP -HPLC Method for Analysis of Eletriptan


Author(s): N.UshaRani1*, R.Sreenivasa Rao1, K.Sarswathi2and TEGK. Murthy3

A simple, rapid and precise Reversed phase high performance liquid chromatography method was developed for the analysis of Eletriptan. Chromatographic separation of Eletriptan is performed by using a Phenomenex Chromosil C18(250 x 4.6mm, 5 μm) column as stationary phase. A mobile phase comprising of Acetonitrile, Triethylamine (TEA) and Tetrahydrofuran (THF)in the ratio of 50:25:25(v/v/v) (pH is adjusted to 6.3 with 1% ortho phosphoric acid) at a flow rate of 1.0ml/min and UV detection at 228 nm. The method is validated as per ICH and FDA guidelines. Linearity was observed in the range of 30-100 μg/ml. Recovery values are found to be 99.04 to 101.99%. The % RSD values for method precision and system precision are found to be less than 2%. The limit of detection and limit of quantification of method was found to be 0.8μg/ml and 2.5μg/ml respectively. The method was able to determine the stability of drug from pharmaceutical dosage form exposed to various stress conditions such as acidic, basic, photolytic oxidative, hydrolytic, and thermal degradation. Well-separated degrading peaks of Eletriptan are observed from the chromatograms of the samples subjected to stability studies.

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