Identification Analysis Of Ketoconazole
PREFORMULATION STUDIES
Preformulation may be described as the process of optimizing a drug through determination and identification of those physical and chemical properties considered important in the formulation of a stable, effective and safe dosage form. Preformulation studies focus on those physicochemical properties of the compound that could affect drug performance and development of an efficacious dosage form. These Preformulation investigations merely confirm that there are no significant barriers which may influence the formulation design and method of manufacture of drug product. The Preformulation studies which were performed in this project include identification of drug (IR spectra and absorption maxima), solubility …show more content…
Ltd., (Mumbai). Identification studies of drug Ketoconazole indicated that the supplied drug was matching with standards as prescribed in I.P. and U.S.P procedures. A UV absorption maximum of drug was found to be 244 nm (Fig. 4.1). An Infrared spectrum of the drug was concordant with the reference spectra (Fig.4.2 and Fig. 4.3).
Solubility Profile of Ketoconazole different solvents indicated that the drug was freely soluble in methanol, methylene chloride and insoluble in water, ether and slightly soluble in PBS (pH 7.4), dichloromethane and very slightly soluble in chloroform, alcohol etc.
Partition coefficient of the drug was found to be 5.057 in n-octanol: Phosphate buffer solution (pH 7.4) suggesting the drug to be lipophilic in nature.
Standard curves of Ketoconazole were prepared in different fluids i.e. PBS (pH 7.4) and methanol. The R2 values are 0.9987, 0.9983 and a straight line was obtained in both the cases in the range of 2-20g/ml. This confirms that the Beer-Lambert's law was followed in the used range in UV Spectroscopy (Fig. 4.4 and
Preformulation may be described as the process of optimizing a drug through determination and identification of those physical and chemical properties considered important in the formulation of a stable, effective and safe dosage form. Preformulation studies focus on those physicochemical properties of the compound that could affect drug performance and development of an efficacious dosage form. These Preformulation investigations merely confirm that there are no significant barriers which may influence the formulation design and method of manufacture of drug product. The Preformulation studies which were performed in this project include identification of drug (IR spectra and absorption maxima), solubility …show more content…
Ltd., (Mumbai). Identification studies of drug Ketoconazole indicated that the supplied drug was matching with standards as prescribed in I.P. and U.S.P procedures. A UV absorption maximum of drug was found to be 244 nm (Fig. 4.1). An Infrared spectrum of the drug was concordant with the reference spectra (Fig.4.2 and Fig. 4.3).
Solubility Profile of Ketoconazole different solvents indicated that the drug was freely soluble in methanol, methylene chloride and insoluble in water, ether and slightly soluble in PBS (pH 7.4), dichloromethane and very slightly soluble in chloroform, alcohol etc.
Partition coefficient of the drug was found to be 5.057 in n-octanol: Phosphate buffer solution (pH 7.4) suggesting the drug to be lipophilic in nature.
Standard curves of Ketoconazole were prepared in different fluids i.e. PBS (pH 7.4) and methanol. The R2 values are 0.9987, 0.9983 and a straight line was obtained in both the cases in the range of 2-20g/ml. This confirms that the Beer-Lambert's law was followed in the used range in UV Spectroscopy (Fig. 4.4 and