Abstract

METHOD DEVELOPMENT AND VALIDATION OF RIFABUTIN BY RP-HPLC TECHNIQUE

Swapnali S. Mankar*, Pradip A. Shelke, Dinesh S. Wanjari, Swati Daware and Dr. D. R. Mundhada.

ABSTRACT

In pharmacy analytical chemistry is responsible for developing sensitive, reliable and more accurate methods for the estimation of drug in pharmaceutical dosage form. Chromatography is the method for the separation of the components of a sample, in which the components are distributed between two phases, one of which is stationary while the other moves. the chromatographer can separate compounds from each other using HPLC; the extent or degree of separation is mostly determined by the choice of stationary phase and mobile phase. Various components of HPLC system are solvent delivery systems, which include a pump, associated pressure and flow controls and filter on the inlet side, Sample injector system, Column, The detector, Data collection device. For study different kinds of reasons for developing new method for Analysis. There is no any suitable method for a particular compound or combination of that compound. The existing method may be too error, contamination prone, be too expensive, time consuming or may not be easily automated, may be having less accuracy or precision. The developed method was validated as per ICH guidelines in terms of specificity, linearity, accuracy, precision, system suitability. The low value of %RSD (less than 2) indicates high precision of the method. The result did not show any statistical difference between operators suggesting that method developed was rugged.

Keywords: HPLC, Validation, ICH guideline, Precision, Accuracy.