Analytical Methods

Hypertension (HT) is a very common disorder, particularly for past middle age. It is not a disease in itself, but is an important risk factor for cardiovascular mortality and morbidity. For improved treatment of hypertension, Telmisartan and Benidipine HCl is the newer combination in market, this combination was developed to improve medication for Stage II hypertension. The aim of this review is to focus on comprehensive update of different analytical methods used for estimation of anti-hypertensive drugs like Telmisartan and Benidipine HCl for the treatment of hypertension. This review delivers a detail description on different analytical methods like UV and RP-HPLC for Telmisartan and Benidipine HCl individually and combination with other drugs. For this review, data searches were conducted by scientific papers in the literature as well as in official compendium. All reported methods are found to be simple, accurate, economic, precise and reproducible in nature.

The current practice of characterization and control of impurities in pharmaceuticals is reviewed with emphasis on issues specific to the generic industry. This review includes an overview of FDA, ICH, TGA, TPD and EMEA guidelines related to impurities in Drug Substance and Drug Products. This introduces the identification, characterization and qualification procedures for ANDAs and approaches to the establishment of acceptance criteria for both drug substance and drug product and significance of analytical methods in total process.