Method Validation is used to analyze the specific and effective testfor identification of active

600 WordsApr 23, 20193 Pages
Method Validation is used to analyze the specific and effective testfor identification of active ingredient. Method validation can be confirmed for their quality, reliability and consistency of analytical results. In this study a simultaneous method for combined two drugs will be discussed.An assay consisted of isocratic elution of Flurbiprofen and Famotidine in Prepacked Column RT 250-4.6 Purospher® STAR RP-18 endcapped (5 µm), using mobile phase composed of acetonitrile, phosphate buffer (pH 3.7) in the ratio of 1:1, respectively. Flurbiprofen and Famotidine were detected at 265 nm at the flow rate of 1 ml/min. The method was found to be sensitive and linear in the range of 10 to 100 ppm with 0.999 coefficient of correlation for…show more content…
Main advantage of combined therapy is to counteract the destructive effects of one drug by reducing the metabolic effects that occur due to maximal dosage of single dosage form [7]. Bi-layer tablets are novel drug delivery system in which two drugs are combined in a single unit.They are advantageous due to the administration of two drugs in a single unit,counter the physical and chemical incompatibilities,patient compliance as sustained release and immediate release in the same dosage [8] . Method Validation is used to affirm the analytical method used for specific test is suitable for its intended use. Results of method validation can later be confirmed for their quality,reliability and consistency of analytical results. It is the major constituent of any good analytical practice.Analytical methods are validated and revalidated before their routine practice use, when there is a change in condition or from its original values.Various methods have been discussed in the literature for determination of Famotidine and Flurbiprofen tablets like spectrophotometric analysis [2], potentiometric [9], Electrochemical, Flow injection analysis FIA. Among them, High performance liquid chromatography is precise, specific, rapid and simple. There is a need of such HPLC methods for detection of two drugs in a single dosage form.The object of this study was to formulate the

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