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Abstract

APPLICATION OF QUALITY BY DESIGN QbD IN DEVLOPMENT OF HPLC METHOD FOR FAMCICLOVIR

*Sheikh Shahed, Masarrat Majid Khan and Dr. Jaiprakash Sangshetti

Abstract

The development of HPLC Method for Antiviral Drug called Famciclovir was carried out using Quality by Design Approach. The Study Started with the development of UV Method for Famcicolvir followed by its Validation as per ICH Guidelines. Further HPLC Analysis was carried out on a Shimadzu HPLC SILADvp Model Chromatograph equipped with a LC20 AT Isocratic Delivery System (pump) SPD-10Avp Detector. The Analytical Column used was C-18 Column [3.9x300 mm] 10 um particle size. The mobile phase used consist of Buffer (Potassium di hydrogen Phosphate: Acetonitrile) in 90:10 ratio. The factors like wave length and flow rate was found to becritical parameters to maintain the method development of HPLC. Hence Box-Behnken optimization models were applied for the main interactions and quadratic effects of these three factors on the selected response. Furthermore, the effects of these parameters was studied on tailing factor (Resolution) by using the surface diagram, the results of these study were analyzed.

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