Vol 9, Issue 2, 2016 Online - 2455-3891 Print - 0974-2441 A COMPARATIVE STUDY ON THE QUALITY OF DIFFERENT OLMESARTAN TABLETS AVAILABLE IN THE ALBANIAN MARKET BRUNILDA BASHA, LEDJAN MALAJ, ELTON MYFTARI* Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Medicine, Tirana, Albania. Email: myftaritoni@yahoo.com Received: 14 October 2015, Revised and Accepted: 21 December 2015 ABSTRACT Objective: Olmesartan (OLM) is the latest molecule of registered and marketed in Albania for the treatment of arterial hypertension. This study aims to carry out a quality control (QC) test on all the alternatives available in the Albanian market and evaluate if there are any outstanding differences terms of quality as it is in terms of price. Methods: There were carried out various QC pharmacopeias tests on a range of different productions of OLM 20 mg tablets. There have been carried out weight variation test, setting the diameter, thickness, friability, hardness, disintegration, and dissolution test. The pharmaceutical equivalents were compared to the reference product in terms of similar dissolution factor (f 2 ) of dissolution profiles and the dissolution efficiency. The dissolution test was carried out using Varian dissolution apparatus 2 (50 rpm, 37±0.5°C); Varian Prostar high-performance liquid chromatography was used to determine the OLM concentration at wavelength 250 nm; Varian hardness VK 200, Guoming BJ-2 disintegration apparatus were used for the respective tests. Results: The study showed that although there is a consistent difference in market price, their quality is comparable. The dissolution profiles were very similar. All formulations met the standards of the United States Pharmacopoeia. Conclusion: All tablets were within the pharmacopoeia limits. The present study confirmed that the difference in price not always represents a difference in terms of quality. Keywords: Olmesartan medoxomil, Quality control, Pharmacopoeia standards. INTRODUCTION According to the data of Global Burden of Disease, arterial hypertension (AHT) is the second risk factor for all other kind of diseases in Albania for 2010 after the risk factors in connection with diet (Fig. 1) [1,2]. Olmesartan (OLM) is the latest molecule from the group of an antagonist of angiotensin inhibitor registered and marketed in Albania. It is one of the preferred preparations available for the treatment of AHT and part of the national reimbursement list. OLM medoxomil is 5-methyl-2-oxo-2H-1,3-dioxol-4-yl) methyl 4-(2-hydroxypropan-2-yl)-2-propyl-1-({4-[2-(2H-1,2,3,4-tetrazol-5-yl) phenyl] phenyl} methyl)-1H-imidazole-5-carboxylate (Fig. 2). It is a potent and selective angiotensin AT1 receptor blocker [3] which has been approved for the treatment of hypertension in the US, Japan, European countries, and Albania. The drug contains a medoxomil ester moiety and is cleaved rapidly by an endogenous esterase to release the active metabolite OLM. So, it was decided to carry out a quality control (QC) for different products OLM medoxomil sold in the Albanian pharmaceutical market. 4 generic drugs OLM medoxomil 20 mg were the subject of this study. METHODS Four different products OLM medoxomil purchased directly from pharmacies in Tirana, Albania (Table 1). OLM medoxomil as reference standard; analytical balance APX-20 “Denver instrument; ph meter ultrabasic “Denver instrument”; It was conducted a United States Pharmacopoeia (USP) method for dissolution test; all chemicals and reagents were high-performance liquid chromatography (HPLC) grade, acetonitrile (9.8% pure); potassium phosphate monobasic (136.9 g/mol), phosphoric acid concentrated, a Varian ProStar HPLC system DAD detector, manual Rheodyne loop injection. The separation was performed on an analytical 250 × 4.6 mm Eurospher 100 −5 C18 (5 μm, particle size) column. The wavelength was set at 250 nm. The mobile phase was a mixture of acetonitrile: Phosphate buffer (17:33) at pH 3.4 was selected a flow rate of 1.5 mL/min. The mobile phase was prepared daily and degassed by ultrasonication for 5 minutes before use. The QC tests of tablets consisted of hardness, shape, diameter, thickness, disintegration, dissolution, percentage of content of the active ingredient. Weight variation 20 tablets per each production of OLM medoxomil were weighted one after the other through an analytical balance, and it was calculated the average weight per each product. It was calculated as well the standard deviation (SD) [4]. Hardness The hardness of 10 tablets per each product was measured using Varian VK200. Then, it was calculated the mean value and respective SD (Table 2) [5]. According to USP, the value of hardness of tablets should vary from 4 to 10 kgf. Diameter and thickness Diameter and thickness of 10 different tablets for each production are measured by Caliber WT. It is calculated the mean value of diameter and thickness along with the SD [6]. Disintegration 6 tablets of each sample were the subject to a disintegration test using Guoming BJ-2 apparatus set at 30 cycles/min, at 37±0.5°C, 1 L of distilled water as medium. Research Article