NEED AND APPLICATION OF ANALYTICAL METHOD DEVELOPMENT ON NEW FIXED DOSE COMBINATION OF IRBESARTAN AND ATORVASTATIN IN PHARMACEUTICAL INDUSTRY

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ABOUT AUTHORS:
Paras Virani1,2*, Parul Jain3, Hasumati Raj2, Vineet Jain2
1Research Scholar 2014, Gujarat Technological University, Gujarat
2Quality assurance department, Shree Dhanvantary Pharmacy College, Kim, Surat
3Quality assurance department, Maliba Pharmacy College, Bardoli, Surat
parasvirani@gmail.com

ABSTRACT
Analytical method is primary requirement of the pharmaceutical industry. In pharmaceutical industry various analytical methods is used like chromatography, spectroscopy method, electrochemical method, ion incorporating method, etc. Irbesartan is classified as an angiotensin II receptor type 1 antagonist. Angiotensin II receptor type 1 antagonists are widely used in treatment of diseases like hypertension, heart failure, myocardial infarction and diabetic nephropathy. Atorvastatin is the most efficacious of the currently available HMG-CoA Reductase inhibitors used in anti lipidemic and also used in atherosclerosis, stroke and cardiac risk. In recently approved new fixed dose combination of Irbesartan and atorvastatin in market of Korea so it require analytical method development which help in industry for new drug delivery system development. This review highlights the role, need and application of various analytical techniques for Irbesartan and atorvastatin combination and their corresponding analytical methods in the pharmaceutical industry.

REFERENCE ID: PHARMATUTOR-ART-2313

PharmaTutor (ISSN: 2347 - 7881)

Volume 3, Issue 2

Received On: 08/12/2014; Accepted On: 12/12/2014; Published On: 01/02/2015

How to cite this article: P Virani, P Jain, H Raj, V Jain; Need and Application of Analytical Method Development on New Fixed Dose Combination of Irbesartan and Atorvastatin in Pharmaceutical Industry; PharmaTutor; 2015; 3(2); 43-47

INTRODUCTION:
In the field of pharmaceutical research, the analytical investigationof bulk drug materials, intermediates, drug products, drug formulations, impurities and degradation products and biological samples containing the drugs and their metabolitesis very important. From the commencement of official pharmaceutical analysis, analytical assay methods were includedin the compendial monographs with the aim to characterize the quality of bulk drug materials by setting limits of their active ingredient content. In recent years, the assay methods inthe monographs include titrimetry, spectrometry, chromatography and capillary electrophoresis; also the electro analytical methods can be seen in the literature.[1]

Hypertension frequently coexists with hyperlipidaemia and both are considered to be major risk factors for developing cardiac disease ultimately resulting in adverse cardiac events. This clustering of risk factors is potentially due to a common mechanism. Further, patient compliance with the management of hypertension is generally better than patient compliance with hyperlipidaemia. It would therefore be advantageous for patients to have a single therapy which treats both of these conditions.[2]

Coronary heart disease is a multifactorial disease in which the incidence and severity are affected by the lipid profile, the presence of diabetes and the sex of the subject. Incidence is also affected by smoking and left ventricular hypertrophy which is secondary to hypertension. To meaningfully reduce the risk of coronary heart disease, it is important to manage the entire risk spectrum. For example, hypertension intervention trials have failed to demonstrate full normalization in cardiovascular mortality due to coronary heart disease. Treatment with cholesterol synthesis inhibitors in patients with and without coronary artery disease reduces the risk of cardiovascular morbidity and mortality and beneficial effect for treatment in coronary heart disease.[3]

Irbesartan, an angiotensin II receptor antagonist, is used mainly for the treatment of hypertension. It is an orally active nonpeptide tetrazole derivative. IUPAN name of irbesartan is 2-butyl-3-({4-[2-(2H-1,2,3,4-tetrazol-5-yl)phenyl]phenyl}methyl)-1,3-diazaspiro[4.4]non-1-en-4- one. These are organic compounds containing a biphenyl attached to a tetrazole. Atorvastatin is a member of the drug class known as statins. It’s mainly used in antilipidemic agent in cardiac risk condition. It is used for lowering cholesterol. Atorvastatin is a competitive inhibitor of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase, the rate-determining enzyme in cholesterol biosynthesis via the mevalonate pathway.[4, 5]

In recentlyHanmi pharmaceutical give patent for the combination use of newly develop combination of antihypertensive and antilipidemic drug for coronary artery disease.[6] here the antihypertensive agent used as irbesartan and antilipidemic agent is atorvastatin give safely and effective treatment. it is mainly used in to the hypertension with diabetic patient and also for cholesterol lowering purpose. This combination of atorvastatin and antihypertensive agents like irbesartan and losartan treat subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidaemia and to treat subjects presenting with symptoms of cardiac risk, including humans. additive and synergistic combinations of atorvastatin and irbesartan whereby those synergistic combinations are useful in treating subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidaemia and those subjects presenting with symptoms of cardiac risk, and congestive heart failure and coronary artery disease.

Irbesartan and atorvastatin Combination is also used in Postprandial Endothelial Dysfunction, Oxidative Stress, and Inflammation in Type 2 Diabetic Patients.[7] The possibility of reducing NT generation during acute hyperglycaemia with irbesartan. Atorvastatin and angiotensin and type 1 (AT-1) receptor blockers (irbesartan) are widely used in preventing CVD and diabetic complications, and it has been suggested that many of their ancillary effects are due to strong intracellular antioxidant activity. Mechanisms underlying the biological effects of atorvastatin and irbesartan differ, even in terms of intracellular antioxidant activity.

Recently no formulation available in USA, INDIA and other country but the fixed dose combination is taken marketing approval in Korea for combination of Irbesartan and atorvastatin. So this new combination requires analytical method development for helping to Pharma industry for new formulation development, clinical tails, and preformulation study.

ANALYTICAL METHOD DEVELOPMENT:
From the stages of drug development to marketing and post marketing, analytical techniques play a great role, be it understanding the physical and chemical stability of the drug, impact on the selection and design of the dosage form, assessing the stability of the drug molecules, quantitation of the impurities and identification of those impurities which are above the established threshold essential to evaluate the toxicity profiles of these impurities to distinguish these from that of the API, when applicable and assessing the content of drug in the marketed products. The analysis of drug (Irbesartan and atorvastatin) and its metabolite which may be either quantitative or qualitative is extensively applied in the pharmacokinetic studies. This review highlights the role of various analytical techniques and their corresponding analytical methods in the analysis of pharmaceuticals.[8]

The present state-of-the art for analytical method is replicated through the data in Table based on the edition of European (The European Pharmacopoeia and Council of Europe, 2002) and US (United States Pharmacopoeia, 2004) pharmacopoeias.


Figure 1: analytical method according EP and USP[9]

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