Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF NADIFLOXACIN AND MOMETASONE FUROATE IN SEMISOLID DOSAGE FORM

*Naik Shreya N. and Desai Shuchi M.

Abstract

Simple, rapid, accurate and precise spectrophotometric methods for Simultaneous estimation of Nadifloxacin and Mometasone Furoate in Combined dosage form has been developed. During extraction for assay of marketed formulation cream (NADIREST-M CREAM) it was found that preservative have shown interference in assay i.e. Chlorocresol. So, during development of method chlorocresol was also taken in consideration. First method, Absorbance Correction method employs solving of mathematical equation using Absorptivity coefficient at 324 nm for estimation of Nadifloxacin (Zero absorbance of Mometasone Furoate and Chlorocresol) and 287-292.5 nm for estimation of Chlorocresol (Zero absorbance of Mometasone Furoate and Zero absorbance difference of Nadifloxacin) and 244 nm for estimation of Mometasone Furoate (Here, absorbance of Nadifloxacin is deducted from total absorbance at 244nm and Chlorocresol show zero absorbance) respectively in Methanol. Second method is Area Under Curve Method (AUC), wavelengths selected for quantitation were 257-272 nm for Nadifloxacin, 241-256 nm for Mometasone Furoate and 221-228 nm for Chlorocresol. These methods were validated as per ICH Q2 (R1) guideline for various parameters like linearity, Precision, Accuracy, Limit of detection (LOD) and limit of quantification (LOQ). Calibration curves were linear over the concentration ranges of 5-25 μg/ml for Nadifloxacin and 0.5-2.5 μg/ml for Mometasone Furoate and 0.5-2.5 μg/ml for Chlorocresol with R2 value were found between 0.9966 to 0.9995 for both methods. Correlation coefficient were found between 0.9982 to 0.9995 for both the drugs and methods. The validation study is statistically significant as all the statistical parameters are within the acceptance range (% RSD < 2.0 and S.D. < 2.0) for both accuracy and precision. %RSD of Intra Day was found to be less than inter day %RSD and %RSD of inter day was found to be greater than Intra Day %RSD. So, these methods can be adopted for Simultaneous estimation of Nadifloxacin and Mometasone furoate in Semisolid Combined dosage form.

Keywords: Nadifloxacin, Mometasone Furoate, Chlorocresol, Simultaneous estimation, Method Validation, Marketed Formulation.