Abstract
DEVELOPMENT & VALIDATION OF RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF BRINZOLAMIDE AND ITS IMPURITIES IN DRUG SUBSTANCE AS PER ICH GUIDELINES

Vivek Tummala*, Prof. K. Basavaiah and Dr. B. M. Rao

ABSTRACT

The analysis of improved RP-HPLC method for the separation and quantification of Brinzolamide and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Inertsil ODS-3V, 250 x 4.6 mm, 5μm, and the mobile phase consists of two Channels A and B. Channel-A pH 5.50 buffer: Acetonitrile (80:20 %v/v) and Channel-B: pH Acetonitrile: Methanol: Water (80:10:10%v/v). The flow rate is 1.0 ml/min. The column temperature was maintained at 25°C and sample temperature was maintained at (15°C) and wavelength fixed at 230nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Brinzolamide impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Keywords: Brinzolamide, estimation of related substances, liquid chromatography.


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