DEVELOPMENT AND VALIDATION OF UV SPECTROMETRIC METHOD OF ECONAZOLE NITRATE CO-CRYSTAL LOADED IN GEL FORMULATION

A simple, fast, inexpensive, and reliable UV spectrometric method was developed and validated to quantify Econazole Nitrate incorporated in topical gel in the form of co-crystal. This article presents the development and validation of different methods for quantification of Econazole nitrate co-crystal loaded in the topical gel as per ICH [Q2(R1)] guidelines. In method-A, the standard and sample solutions were prepared in Methanol; in Method-B the solution was prepared in a mixture of Methanol: phosphate buffer pH7.4. Based on analysis of UV spectrum, different wavelengths were selected for analysis of drug by two methods, 220 nm was selected for method A whereas 265 nm was selected for method B. The linearity of drug was obtained in the concentration range 2-10 μg/mL (R2= 0.9988) in method-A and concentration range 20-100 μg/mL (R2= 0.9984) in Method-B. The accuracy of both method was checked by calculating % recovery at 80percent, 100percent and 120percent. The % recovery by both methods was obtained to be in the range of 80-90percent. The less values of %RSD indicate the accuracy of both methods. The method’s precision was designed as an intraday, inter-day repeatability. The %RSD value is less than 2 indicates that both the methods are precise. The robustness of both methods was examined with the help of ± wavelength and two ±pH values of the buffer used. The described analytical methodology is simple, precise, accurate and robust and can be applied for the quantification of ECZN in pharmaceutical dosage forms.