European Journal of Biomedical and Pharmaceutical Sciences

METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF FLAVOXATE HYDROCHLORIDE IN TABLET DOSAGE FORM

Sathish Kumar Konidala* Sri Lakshmi Rapaka, Govinda Rao K, and Vinod Kumar M

ABSTRACT

A stability-indicating gradient RP-HPLC method has been developed for the estimation of impurities of Flavoxate Hcl in pharmaceutical formulations. Efficient chromatographic separation was achieved on a Inertsil ODS-3V (150×4.6 mm, 5μ) column with mobile phase containing a gradient mixture of solvents A and B. The flow rate of the mobile phase was 1 mL/ min with column temperature of 25°C and detection wavelength at 293nm. Regression analysis showed an r value (correlation coefficient) greater than 0.999 for Flavoxate Hcl. Flavoxate Hcl formulation sample was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Flavoxate Hcl was found stable degrade significantly in Acid stress condition. The degradation products were well resolved Flavoxate Hcl, and their impurities. The peak purity test results confirmed that the Flavoxate Hcl peak was homogenous and pure in all stress samples thus proving the stability-indicating power of the method. The developed method was validated according to ICH guidelines with respect to specificity, linearity, limits of detection and quantification, accuracy, precision, and robustness.

Keywords: Stability indicating RP-HPLC method; Flavoxate Hcl, Method validation; Gradient technique.