RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF BALSALAZIDE IN BULK AND CAPSULE DOSAGE FORM

G. Parimala*, D. Narasimharao, M. Prasadarao

A RP-HPLC method was developed for the estimation of Balsalazide in bulk and Capsule dosage form and the method was proposed for the validation for the parameters like accuracy, precision, linearity, range, robustness, ruggedness, % of recovery and limit of detection and limit of quantitation. Still now there were number of analytical methods were developed for the estimation and validation of Balsalazide alone and in combined dosage form like UV-Visible spectroscopy, fluorimetry and RP-HPLC method but compared to those methods the present study was a simple and selective LC method for the quantitative estimation of Balsalazide in capsule dosage form. Chromatographic separation was achieved on a c18 column using Inertsil ODS 3V column, C18 (250x4.6 ID) mobile phase consisting of a mixture of KH2PO4:ACN:MEOH (50:30:20 v/v/v %)PH : 4.5 with detection of 304 nm. The retention time was found to be 2.487 min and linearity was observed in the range 90-210µg /ml for Balsalazide. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2.