A new RP HPLC based analytical method development and validation for selected commercial drug molecules in bulk and pharmaceutical dosage forms

Abstract

Macromolecules, polymeric materials, ionic species, labile natural newlineproducts, and different type s high-molecular-weight poly functional group newlinecan all be separated using HPLC Bisoprolol is phenoxy-2-propanol-derived newlinecardio selective beta-1, which is adrenergic receptor antagonist with newlineantihypertensive and potential cardio protective activities. Basically, newlineEstimating the amount of fumaric acid present in the salt form is an important newlinefactor for its Food and Drug Administration (FDA) specification. Even newlinethough numerous revealed for the estimation of organic acid content in any newlineedible or medical materials, convention titrimetric methodology is most newlinecommonly employed for its estimation. Particularly for bisoprolol fumarate newlineestimation done by conventional titration method. According to Indian newlinepharmacopeia potentiometric titration method is used for fumaric acid newlineestimation by using tetra butyl ammonium hydroxide and standard calomel newlineelectrode. Hence finding suitable method for the fumaric acid estimation by newlinechromatographic method is a highly desirable in pharmaceutical industries. newlineChromatographic based protocol offers high accurate, reliable and more rapid newlineresults. In this chapter, we have developed a RP-HPLC-based method to newlineestimate the fumaric acid content in bisoprolol and validated. The degradation newlinestudies were also performed to understand the stability of developed method. newline