DEVELOPMENT AND VALIDATION OF UV SPECTROMETRIC METHOD OF ECONAZOLE NITRATE CO-CRYSTAL LOADED IN GEL FORMULATION
AbstractA 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.
Article Information
31
5057-5067
791 KB
399
English
IJPSR
Priyanka S. Gala *, Mohammad Wais and Ojaswi Ghadge
Department of Pharmaceutics, HK College of Pharmacy, Oshiwara, Jogeshwari [W] Mumbai, Maharashtra, India.
galapiyu1998@gmail.com
07 April 2022
26 May 2022
16 June 2022
10.13040/IJPSR.0975-8232.13(12).5057-67
01 December 2022