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Assessment of Endogenous Biochemical Composites Emphasizing Drug Interaction of Cardiovascular Combined Dosage Formulation in Marketed Product

Tapan Kumar Pal
2014 Journal of Pharmacovigilance  
The study reveals the investigational approaches of a Cardiovascular formulated tablet dosage i.e, Atorvastatin (ATVS) & Olmesartan (OLM) after getting negative feedbacks on pharmaceutical market. A simple, sensitive, precise and rapid analysis under highly sophisticated LCMS/MS system to evaluate the endogenous biochemical composites like Aldosterone (ALD), Angiotensin-II (ANG-II) and Mevalonate (MVA) in plasma concentration level, which associate with mentioned drugs pharmacology. The methods
more » ... cology. The methods were developed and validated for the same to analyze plasma concentration level among 20 patient volunteers pre-administered with targeted combined tablet dosage. Chromatographic peaks of standard and internal standard exhibits excellent regression curve line and correlative coefficient, r 2 =0.998, 0.999 & 0.999 of ALD, ANG-II & MVA respectively. The quality control profile of accuracy, mean% recovery is range between 90.6-99.13% & 88.2-96.3% respectively of endogenous bio-analytes. And inter-day & intraday precision % RSD (Relative Std. Dev.) is ranges from 1.60-1.90 of the same. Analytical reports represent the lower concentration of ALD after ATVS (Atorvastatin)+OLM (Olmesartan) therapy compare to without drug. But, in case of ANG-II, it is completely inverse and MVA conc. lowers equally in ATVS+OLM and ATVS (individual therapy). ALD & ANG-II are physiologically responsible for hypertension while MVA for cholesterol biosynthesis. Thus, study concludes that OLM bioavailability approaches get retarded in compare to unchanged bio-availability of ATVS in the combined (ATVS+OLM) formulation and stands weak antihypertensive activity compare to individual therapy, reason might be due to pharmacokinetic interaction. So, its fails the expected synergism.
doi:10.4172/2329-6887.1000150 fatcat:nicx3l7wj5epnjpztjznawbbqy