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Comparative in vitro evaluation of aceclofenac and paracetamol combination tablets marketed in Andhra Pradesh

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Author: 
Venkateswara Rao, S., Anitha, M. and Padmalatha, K
Abstract: 

Aceclofenac in combination with Paracetamol is now available in the market and indicated in pain, fever etc. These tablets manufactured and marketed by various multinational and local companies. In this study eight marketed brands of Aceclofenac & Paracetamol combination tablets have been evaluated using physicochemical properties and in vitro dissolution test with the object to assess bioequivalence and select a potent generic brand for reducing cost of the treatment. A simple high performance liquid chromatographic (HPLC) method was developed for the simultaneous determination of Aceclofenac & Paracetamol. The retention time of Aceclofenac & Paracetamol were found to be 4 ± 0.2 and 3 ± 0.2. The in vitro dissolution studies were performed in USP Dissolution Apparatus II using pH 6.8 phosphate buffer solutions separately for 45 minutes. The amount of Aceclofenac & Paracetamol released at different time intervals were estimated by HPLC method. In vitro dissolution of all the brands was satisfactory, the brand Spanac-p® showed higher drug release, respectively 79.32 % of Aceclofenac & 95.04 % Paracetamol within 45 minutes. The f1 and f2 values were in the range of 5 – 13 and 64 – 86 respectively. This suggests that release of Aceclofenac & Paracetamol from all brands were similar with reference. Therefore it is evident that test products were bioequivalent to the reference product and the brand Spanac-p ® could be used as a best generic substitute which reduce the dose and cost of the treatment.

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