amlodipine, tablet division, efficacy, stability


Tablet division is a widespread phenomenon nowadays in Albania, because of different factors such as the absence of small dosages in the pharmaceutical market, financial reasons etc. The purpose of this study is to identify the positive and negative aspects of tablets division by patients. It aims to show experimentally if the division affects or not, in a significant way the percentage of the active substance. It was selected Amlodipine as a drug for analysis, because of two reasons. First it is used in chronic therapy and second it is part of the List of Reimbursement of Medicines in the Republic of Albania.It was used besylate amlodipine as RS, three different productions of Amlodipine tablets bought directly in a community pharmacy, methanol HPLC grade and ammonium acetate. It was selected the method based on the HPLC analysis of the solutions obtained by dissolution of amlodipine in methanol as described in the European Pharmacopoeia 2011. This was an ongoing analysis for four weeks. The divided tablets have been kept in similar conditions as a patient can do.The organoleptic control after division showed no changes for all three productions. Only halves of sample A fulfill the pharmacopoeia criteria for RD ± 7.5%. From the results obtained, it was noted that there was a decrease in the percentage of the active substance, on halves taken randomly for analysis. The concentration of the active substance in sample A at the end of the analysis resulted to be 83.6%, in sample B 84.37% and sample C 83.75%. The level of impurities remain ≤ 2% conform limits in Eur. Ph. Based on these results, it is concluded that tablet division is a process that significantly affects the percentage of the tablet's active substance. Reducing the concentration of the active substance implies that the patient does not receive the required dose for treatment and the success of therapy is in doubt. The division of amlodipine tablets is economically convenient, but is a practice that should be avoided and not advised by the healthcare providers.



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