The present research article describes the method development and validation of ketoconazole by an innovative HPLC method in dosage form that is solid in nature i.e tablets. Inertsil ODS-C18 column (150mm, 4.6mm, and 5μm) was used for the study and mobile phase consists of buffer (pH-4) and Methanol in the mixture of 30:70. Wavelength for the chromatographic separation used was 274 nm. Injection volume was maintained at 20μl. A wide variety of mobile phase combinations used for the study and system contains integrated degasser. A flow rate was maintained at 1ml/min throughout the process for mobile phase combinations. Average recovery found out to be 101.112, 99.862 and 98.573 respectively, standard deviation was 0.9340987, 0.9819543 and 0.9852619 and %R.S.D was 0.9238260, 0.9833150 and 0.9995260. In this method ICH guidelines were used for validation studies. After analysis of different research and review articles it came to light that HPLC method development of ketoconazole has been done in different dosage forms but less work is done on solid dosage forms and hence still there is enormous potential for new methods to be developed in solid dosage form with different mobile phase combinations. The limit of detection and quantitation was found out to be 0.809077855 and 2.451751077.
Keywords: Ketoconazole, Linearity, ICH