Tirumala Rao, et al.: Stability-indicating RRLC Method for Irbesartan A green, novel gradient stability-indicating reverse phase rapid resolution liquid chromatographic method was developed and validated for simultaneous estimation of irbesartan and along with six related impurities in active pharmaceutical ingredient samples. The chromatographic separation was achieved on Kromasil C8 (3.5 µm, 150×4.6 mm) short column with 0.1% v/v ortho-phosphoric acid and acetonitrile as mobile phase using gradient elution. The developed method showed good resolution between irbesartan and its six related impurities and were eluted within 15 min. run time of LC chromatogram. Regression analyses indicate correlation coefficient value greater than 0.999 for irbesartan and its six related impurities. The limit of detection for irbesartan and the known related impurities were observed at a level below 0.004% (0.019 µg/ml and the method is showing better recoveries for irbesartan (99.6-100.7%) and also for its six known impurities (88.5-98.9%). The test solution and related substances were found to be stable in the diluents for 24 h. The developed stability-indicating method is found to be rapid, accurate, precise, linear, specific, sensitive, rugged, robust, and stability-indicating. The application of developed method was also verified by an assay of irbesartan and related substances in commercial bulk drug samples and more essentially, the method is economic and environment friendly than the other published methods.
Key words: Irbesartan RRLC, stability-indicating, related substances, validationIrbesartan (IRB) is chemically described as 2-butyl-Its empirical formula is C 25 H 28 N 6 O, and molecular weight is 428.5 amu. IRB is an active non-peptide specific angiotensin II receptor antagonist (AT1 subtype) used as antihypertensive agent. Hypertension is the most prevalent cardiovascular disease in the developed as well as developing countries, affecting as many as one quarter of the adult population.Furthermore, hypertension is an independent risk factor for cardiovascular diseases and associated with an increased incidence of stroke and coronary heart disease. Angiotensin II antagonists are major drugs used in hypertension management in the recent decade. Their lower side effect profile and specificity in the action provided a good condition for patient compliance as well as effectiveness. Therefore, these drugs are used as first line treatment for hypertension [1][2][3][4] . Stability testing of new drug substances and drug products requires a stress testing, which should be carried out to elucidate the inherent stability characteristics of the active substance. It suggests that the degradation products, which were formed under variety of conditions, should be identified and degradation pathways are to be established [5] . The literature survey reveals that several methods [6][7][8][9][10][11][12][13] were reported for the determination of IRB and hydrochlorothiazide. The methods [14][15][16][17] for IRB in combination with ot...