A REVIEW ON METHOD DEVELOPMENT & METHOD VALIDATION BY RP HPLC FOR ESTIMATION OF ARFORMOTEROL

Krishnaphanisri Ponnekanti, Addanki Anusha, B. Raj Kamal, Durga Bhavani Dasari, Sumana Reddy Gargula and Shiva Reddy Karnati

Arformoterol is a long-acting β2 adrenoreceptor agonist (LABA) and it is the active (R, R)-(−)enantiomer of formoterol. It was approved for medical use in the United States in October 2006. It is available as a generic medication. Arformoterol is indicated for the maintenance treatment of bronchoconstriction in people with chronic obstructive pulmonary disease (COPD). The purpose of analytical method development is to establish the identity, purity, physical characteristics, and potency of drugs, including the drug’s bioavailability and stability. Method development and validation can be understood as the process of showing that analytical procedures are adequate for the purpose of assessing drugs, and particularly the active pharmaceutical ingredient (API). Analytical procedures are developed to test specific characteristics of the substances against the predefined acceptance criteria for such characteristics. Thus, analytical method development involves the evaluation and selection of the most precise assay procedures to determine the composition of a drug. Method validation provides an assurance of reliability during normal use, and is sometime referred to as “the process for providing documented evidence that the method does what it is intended to do.” The main objective of the validation is to demonstrate that the analytical method is suitable for its intended purpose, is accurate, specific and precise over the specified range that an analyte will be analyzed. Analytical Method Validation is to be performed for new analysis methods or for the current methods when any changes are made to the procedure, composition of the drug product and synthesis of the drugs substances.