Validation of UV-Spectrophotometric and RP-HPLC methods for the simultaneous analysis of Paracetamol and Aceclofenac in marketed tablets

The aim of the study was to develop UV-spectrophotometric and RP-HPLC methods for the simultaneous analysis of paracetamol and aceclofenac in marketed tablets. The methods were validated in terms of linearity, accuracy (% Recovery), precision (inter day, intraday and reproducibility) and robustness. Both the methods were linear (R = 0.997-0.999 for UV method and 0.999 for RP-HPLC method) and accurate (% recovery was 99.19% 100.14%). The method was also found precise (% RSD< 2%) and robust. Potency of three marketed brands was determined by both the methods and no statistically significant difference was noticed between the potency obtained by two methods by paired t test at 5% significance level. Paracetamol released from marketed products was found to comply compendia specification but inter brand variation in case of aceclofenac release was observed by ANOVA (Sig. 0.000). Any one of the validated methods can be used for the analysis of paracetamol and aceclofenac tablets. Key-Words: Paracetamol, Aceclofenac, UV, RP-HPLC, Method validation Introduction Paracetamol is one of the most popular over-thecounter drugs. It has analgesic and antipyretic properties with weak anti-inflammatory activity and it is used in the symptomatic management of moderate pain and fever. When taken at recommended doses it has an excellent safety profile. It is available in different dosage forms: tablet, capsules, drops, elixirs, suspensions and suppositories. The drug is official in different pharmacopeia. Paracetamol is often combined with other drugs (caffeine, aceclofenac) for greater patient acceptability, increased potency, multiple activity, fewer side effects and quick relief. Aceclofenac, [(2-{2,6-dichlorophenyl)amino} phenylacetooxyacetic acid] is a non-steroidal antiinflammatory drug (NSAID) indicated for the symptomatic treatment of pain and inflammation with a reduced side effect profile, especially gastro-intestinal events that are frequently experienced with NSAID therapy. * Corresponding Author: E-mail: [email protected] Tel: +880-2-9664953 Ext-136 Fax: + 88 02 9664950 Aceclofenac is practically insoluble in water with good permeability (calculated log P = 2.170) and belongs to biopharmaceutics classification system (BCS) class II (low solubility, high permeability). Therefore, AC shows dissolution rate limited absorption that gives rise to difficulties in pharmaceutical formulations for oral delivery, which may lead to variable bioavailability. Therefore constant surveillance on marketed paracetamol and aceclofenac tablets by the government, manufactures and independent research groups is essential to ensure availability of quality medicines. Selective and sensitive analytical method for quantitative determination of drugs and their metabolites are essential for successful evaluation of clinical pharmacology, pharmacokinetics (PK), bioavailability (BA) and bioequivalence (BE) studies. Paracetamol is official in BP and USP. Analysis methods are described in these pharmacopeias. But neither aceclofenac tablet nor the combination of paracetamol and aceclofenac is official in BP or USP. So, official analytical methods are not available for simultaneous determination. A number of methods have been reported for the analysis of aceclofenac either by UV or HPLC . Both UV and HPLC Research Article [Islam, 2(12): Dec., 2011]