METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ITRACONAZOLE AND TERBINAFINE HCL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING UV VISIBLE SPECTROSCOPY

In this present study, a simple, effective, and accurate method has been developed for estimating itraconazole and terbinafine in bulk and pharmaceutical dosage form using UV Visible spectrophotometer. Two methods were developed: the simultaneous equation method, also known as vierordt’s method, and the other absorbance ratio method, also known as Q value method. In the simultaneous equation method, maximum absorption was found at 229 nm for itraconazole and at 223 nm for terbinafine. In the absorbance ratio method, two different wavelengths were selected, 229 is being the lmax of one drug and 225nm is another iso-bestic wavelength. The linearity was found in the range of 5 -25µg/ml for both drugs and methods, with the correlation coefficient (R²) of itraconazole and terbinafine is 0.999 for simultaneous equation method. For the absorbance ratio method, itraconazole’s correlation coefficient (R2) is 0.9953 and 0.9877, and terbinafine is 0.9903 and 0.9948. All validation parameters were studied after method development, including linearity, accuracy, precision, limit of detection, limit of quantitation, robustness, and ruggedness as per ICH guidelines. The method was found robust and %RSD was less than 2% for accuracy, precision, and ruggedness. The developed method was suitable for analyzing itraconazole and terbinafine in bulk and dosage form.