Friday , 21 June 2024

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Elbasvir and Grazoprevir Fixed dosage form

Purnacandra Rao Mendu*
Department of Chemistry, Bundelkhand University, Jhansi, Uttar Pradesh, India

A  B  S  T  R A C T
The present research work focused on development and validation for the RP-HPLC method for the simultaneous estimation of Elbasvir and Grazoprevir in bulk and fixed dosage form. Chromatographic separation was achieved on by using Eclipse XDB -C18 (150×4.6mm, 5µm particle size) column and the flow rate was maintained at 1.0 ml/min. The injection volume was 20µl. Separation was carried on gradient mode. The mobile phase A consist of 0.01M Disodium hydrogen Orthophosphate in water and the pH 3.0 was adjusted with Dilute Ortho-phosphoric acid , mobile phase B consist of Acetonitrile. UV detector wavelength monitored at 215 nm and the run time was 15 min. The retention time was found to be 7.158 min for Elbasvir and 5.313 min for Grazoprevir. The linearity was obtained in the range of 300-900 µg/ml for Elbasvir and 600-1800µg/ml for Grazoprevir.  The developed method was validated statically according to ICH guidelines. The proposed method was accurate, precise, reproducible and robust; it can be employed for routine quality control analysis of pharmaceutical formulations.
Keywords: RP-HPLC, Elbasvir, Grazoprevir, Mobile phase, Validation, Retention time

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