Research J. Pharm. and Tech. 3(4): Oct.-Dec. 2010 1 ISSN 0974-3618 www.rjptonline.org RESEARCH ARTICLE Simultaneous Estimation of Aceclofenac and Paracetamol in Bulk and Combined Tablet Dosage Form and From Biological Fluid by Planar Chromatography Poonam P. Patil 1 , Mahesh M. Deshpande 1 , Veena S. Kasture 2 * and Seema A. Gosavi 2 1 Department of Pharmaceutical chemistry, MGV’S College of Pharmacy, Panchvati, Nashik-03 2 Sanjivani College of Pharmaceutical Edu. and Research, Kopargaon, Dist: Ahmednagar, (M. S.), India, 423603 *Corresponding Author E-mail: veenakasture@hotmail.com ABSTRACT: A simple, accurate, reproducible, rapid and precise high-performance thin-layer chromatographic method has been established and validated for simultaneous determination of Aceclofenac and Paracetamol in bulk and combined tablet dosage form and from biological fluids. Both the drugs were separated on aluminum plates precoated with silica gel 60 F254; Toluene: n- Butanol (7:3v/v) was used as mobile phase. Quantitative analysis was performed by densitometric scanning at 263 nm. The R F values of aceclofenac and paracetamol were 0.14 and 0.43, respectively. The calibration plot was linear over the range of 200–1200 ng/spot for aceclofenac and paracetamol, with correlation coefficients, r, 0.9979 and 0.9995, respectively. Recovery of aceclofenac and paracetamol was 100.14–101.80 and 100.04–100.32%, respectively. The suitability of densitometric TLC for quantitative analysis of these compounds was proved by validation in accordance with the requirements of ICH guidelines. The recovery of aceclofenac and paracetamol from biological fluids (albumin and plasma) by solvent - solvent extraction using ethyl acetate: acetonitrile (3:1v/v) was 89- 90% and 90-98% respectively. KEYWORDS: Aceclofenac, Paracetamol, HPTLC, biological fluid. NTRODUCTION: Aceclofenac (ACF), [o-(2, 6-dichloroanilino) phenyl] acetate glycolic acid ester has anti-inflammatory and analgesic properties 1 . ACF inhibits synthesis of the inflammatory cytokines interleukin-1b and tumour necrosis factor, and inhibits production of prostaglandin E2. ACF is used for relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 2 . Paracetamol (PCM), 4-hydroxyacetanilide is a commonly used nonnarcotic, analgesic, antipyretic agent with weak anti-inflammatory activity. PCM blocks prostaglandin synthesis by the cyclooxygenase pathway and inhibits thromboxane A2 formation in platelets, reducing platelet aggregation. PCM is selective inhibitor of COX-3 3-5 . The chemical structures of drugs are shown in Figure 1. Literature survey revealed various analytical methods, such as spectrophotometric, spectrofluorimetric, HPLC, and stability-indicating HPTLC methods for analysis of aceclofenac and paracetamol in a combined tablet dosage form has recently been reported 6-34. Received on 09.05.2010 Modified on 27.05.2010 Accepted on 12.06.2010 © RJPT All right reserved Research J. Pharm. and Tech.3 (4): Oct.-Dec.2010; Page 470-473 No published reports were found on the HPTLC determination of aceclofenac and paracetamol in combined dosage forms by Solvent - Solvent extraction method in biological fluid by RP-HPTLC. The objective of this work was to develop a simple, economical, reproducible, and rapid method for analysis of these drugs in their binary drug formulations. 2. EXPERIMENTAL: 2.1 Reagents and Chemicals: All chemicals and reagents used were of HPLC grade and supplied by S.D. Fine Chemicals, India. Aceclofenac and paracetamol reference standards were provided as gift samples by Ipca laboratory (Mumbai, India) and Cadila pharmaceutical (Ahemadabad, India) respectively. Commercial tablets (ZERODOL-P; Ipca laboratory Ltd,), labelled to contain aceclofenac 100 mg and paracetamol 500 mg, were obtained locally. 2.2 Preparation of Standard Solutions: Aceclofenac (10 mg) and paracetamol (10 mg) were weighed separately and dissolved in 100 mL methanol to furnish solutions of concentration 100 μg /mL for each drug. 2.2.1 Preparation of plasma: Plasma purchased from blood bank was used for preparation of biological samples of the drugs.