RP-HPLC Method for Simultaneous Estimation of Nadifloxacin and Mometasone Furoate in Semisolid Dosage From

Abstract

The objective was to develop and validate an easy, economical, fast, reliable, reproducible, precise and accurate reversed-phase highperformance liquid chromatography (RP-HPLC) method for the estimation of Nadifloxacin and Mometasone furoate in semisolid dosage form. The chromatographic separation was achieved by using the HPLC system equipped with a C-18(2) column (250 × 4.6 mm, Particle size 5µm) at wavelength 254 nm. The mobile phase consisting of Methanol : Acetonitrile : water (pH-4 adjusted with OPA) in ratio of (55:30:15 v/v) was used in isocratic mode. The flow rate was fixed at 1.0 mL/min with a continuous run up to 10 min, while the retention time was located near about 3.870 and 5.377 min for Nadifloxacin and Mometasone Furoate respectively. The dosage form is cream named as NADIREST-M available in market which has Chlorocresol as preservative. So, to see the interference of Chlorocresol it was also estimated and there was no interference in estimation of both drugs by checking system suitability parameters (Chlorocresol peak has resolution more than 2 from the peak of drug). In the concentration range of 50-130 µgmL-1 and 5-13 µgmL-1 Nadifloxacin and Mometasone Furoate respectively, the detector response was found linear with linear regressed equation Y=15116X-365319 and Y=52717X-184314. In the assay of NADI, 99.12% and MOM 99.77% of the drug was recovered. This method proved a satisfactory validation for all the parameters such as accuracy, linearity, specificity, precision, range, ruggedness, robustness, reproducibility as per ICH guidelines. The results of the study evidenced that it is useful for the routine determination of Nadifloxacin and Mometasone Furoate in Semisolid pharmaceutical dosage forms like a cream.