Friday , 12 July 2024

Method Development and Validation for Simultaneous Estimation of Isoniazid and Ethambutol by using RP-HPLC in Bulk and Pharmaceutical Dosage form

Etika Madhu*, Dr. Alagar Raja. M, K.N.V Rao,David Banji
Departmernt of Pharmaceutical Analysis, Nalanda College of Pharmacy, Nalgonda, Telangana, India

A reverse phase high performance liquid chromatographic method was developed for the determination of Isoniazid and Ethambutol in bulk and pharmaceutical dosage form. The separation was carried out on a [Column: Inertsil C18 (4.6 x 250mm, 5µm, Make: Waters)] using a mobile phase mixture of buffer, acetonitrile in a isocratic elution at a flow rate of 1ml/min. The detection was made at 255 nm. The retention time of Isoniazid and Ethambutol was found to be 2.325 and 4.322 min respectively, Calibration curve was linear over the concentration range of 1μg – 5μg and 100μg-500μg of Isoniazid and Ethambutol. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative estimation of related substances in drug and pharmaceutical dosage form.
Keywords: Isoniazid and Ethambutol, HPLC, Validation studies

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