Development of a Rapid Analytical Method on UV Spectrophotometer for Analysis of Trace Level APIs Telmisartan in Cleaning Validation Sample

Abstract

Since the 1990’s, cleaning validations have gained a lot of interest within pharmaceutical and bio-pharmaceutical companies. In 1988, the FDA experienced its first major incident with cross contamination traceable to inadequate cleaning and cleaning validation. The finished drug product, Cholestyramine Resin USP, was recalled due to contamination with low levels of intermediates and degradants from the production of agricultural pesticides. The cross-contamination was believed to have come from the use of drums in the production of the active pharmaceutical ingredient (API). These drums had previously been used to store solvents for the manufacture of agricultural pesticides at another plant. Extra pure methanol procured from Chempura Enterprises Indore of make Merck and Analytical Grade water procured from the SK Traders Indore M.P. Reference materials, Telmisartan from Axiom Analytical Services Indore M.P. HPLC grade methanol (MeOH), HPLC Grade Water were purchased from Chempura Enterprises Indore M.P.. All chemicals were used as received, without any further purification. In recent years, increased emphasis has been placed in pharmaceutical companies for implementing robust validated cleaning procedures. The cleaning procedure is one of the most important tasks to avoid contamination and cross- contamination of APIs in pharmaceutical products manufactured on the same equipment trains. The cleaning procedures must be supported byappropriate analytical methods and related sampling methodologies.