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Abstract

UV METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF FLAVOXATE HYDROCHLRORIDE AND OFLOXACIN USING MIXED HYDROTROPIC AGENT

Md Tausif Iqbal*, Anjana Bhardwaj

Millennium College of Pharmacy, Nathu Barkheda Rd, Near Neelbad, Bhopal (M.P)

ABSTRACT

A simple, accurate, and eco-friendly UV spectrophotometric method was developed and validated for the simultaneous estimation of Flavoxate Hydrochloride (FHC) and Ofloxacin (OFC) in combined tablet dosage form using a mixed hydrotropic agent system. Poor aqueous solubility of both drugs was successfully overcome by employing a hydrotropic mixture of 2 M sodium citrate and 8 M urea (1:1), which provided significant solubility enhancement without interfering with the absorbance maxima of the drugs. FHC and OFC showed maximum absorbance at 291.0 nm and 250.0 nm, respectively. The method exhibited linearity in the concentration range of 5–25 µg/mL for both drugs with correlation coefficients (r²) of 0.999. The proposed method was validated in accordance with ICH guidelines, demonstrating good accuracy with recovery values close to 100%, and excellent precision as indicated by low %RSD values for repeatability, intermediate precision, analyst-to-analyst variation, and reproducibility. The assay of marketed tablet formulation showed satisfactory results with percentage label claims within acceptable limits. The developed UV spectrophotometric method is rapid, economical, precise, and environmentally benign, making it suitable for routine quality control analysis of Flavoxate Hydrochloride and Ofloxacin in bulk and pharmaceutical dosage forms.

Keywords: Flavoxate Hydrochloride, Ofloxacin, UV spectrophotometry, Mixed hydrotropy, Method development, Validation, ICH guidelines.


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