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Abstract

APPLICATION OF QBD IN METHOD DEVELOPMENT OF STAVUDINE

Masarrat Majid Khan*, Jaiprakash Sangshetti, Zeeshan Khan and Asra Mumtaaz Shaikh

ABSTRACT

The HPLC method for Stavudine has been developed using a quality by design concept. In the recent times due to regulatory requirement QbD (Quality by Design) has gained more importance. Chromatographic study has been achieved on a C18 column (3.9 × 300, 10 micron particle size). The mobile phase consists of buffer (mono potassium phosphate): methanol (70:30). The factors like flow rate, injection volume and wavelength was found to be critical to maintain in method development of HPLC. Hence Box-Behnken optimization model was applied for the main, interaction and quadratic effects of these three factors has been studied on the selected response. Effects of these parameters were also studied on tailing factor (resolution). Results were analyzed using surface diagram. The Verification of the software generated result has been carried by using six replicates of the run. Lastly validation of the developed method was carried out by applying guidelines and parameters give by ICH (ICH Guidelines).

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