Journal of Bioequivalence & Bioavailability

Development and validation of a stability indicating RP-HPLC method for the estimation of Troxepide in bulk and its pharmaceutical dosage forms

3^rd World Congress Bioavailability & Bioequivalence

March 26-28, 2012 Marriott Hotel & Convention Centre, Hyderabad, India

N. Mallikarjuna Rao and D. Gowrisankar

Posters: J Bioequiv Availab

Abstract:

A Simple, sensi tive, selective and precise stability indicating reverse phase high-performance liquid chromatographic method for analysis of troxepide in pharmaceutical dosage forms. The method employed column agilent ZORBAX SB-CN (150 ? 4.6 mm, 3.5 μm) as the stationary phase. The solvent system consisted of Phosphate buffer, 25 Mm (the pH was adjusted to 4.0 ? 0.05 with ortho-phosphoric acid) and Acetonitrile (40:60% v/v) at a flow rate of 0.8 ml/min. This system was found to give compact peak for troxepide (Retention time is 2.1 min). troxepide was carried out in the absorbance mode at 260 nm. The linear regression data for the calibration plots showed good relationship with r 2 = 0.99 ? 0.001. The method was validated for precision, accuracy, robustness and recovery. System suitability tests essential for the assurance of quality performance of the method were performed. The method was statistically validated according to International Conference on Harmonization ICH guideline and % RSD was found to be less than 2 indicating high degree of accuracy and precision of the proposed RP-HPLC method. The drug was subjected to stress degradation studies under acidic, basic, oxidative and thermal conditions. Degradation products resulting from stress studies did not interfere with the detection of troxepide and the assay can thus be considered as stability-indicating. Due to its simplicity, rapidness, high precision and accuracy, the proposed HPLC method may be used for determining troxepide in bulk drug samples and in pharmaceutical dosage forms.