Vishnu Choudhari et al. | Int. J. Res. Pharm. Sci. Vol-1, Issue-3, 253-258, 2010 ©Pharmascope Foundation | www.pharmascope.org 253 Development and validation of a RP-HPLC-PDA method for simultaneous esti- mation of Drotaverine and Aceclofenac in a combined dosage form Vishnu Choudhari*, Kunal Ingale, Madhusmita Sahoo, Pratima Syal, Snehal Ingale, Santosh Shinde, Abhijit Sutar, Bhanudas Kuchekar MAEE‘“ Maharashtra IŶstitute of PharŵaĐLJ, “. No. ϭϮϰ, MIT Caŵpus, Paud ‘oad, Kothrud, Pune - 411038, MS, India ABSTRACT A simple, precise, rapid and accurate RP-HPLC-PDA method has been developed for the simultaneous estimation of drotaverine HCl (DRT) and aceclofenac (ACE) in combined tablet dosage form. Formulation containing DRT with ACE are used as antispasmodic and anti-inflammatory agent. The chromatographic separation was achieved on Qualisil BD“ Cϴ ĐoluŵŶ ;ϮϱϬ ŵŵ dž ϰ.ϲ ŵŵ, ϱ.Ϭ μ partiĐle sizeͿ usiŶg ŵethaŶol: THF: aĐetate ďuffer ;ϲϴ:ϭϮ:ϮϬ ǀ/ǀͿ pH adjusted to 5.0 with acetic acid, flow rate was 1.0 mL min -1 and column was maintained at 50 0 C. Quantification and linearity was achieved at 298 nm over the concentration range of 1 - ϭϱϬ μg ŵL -1 for Drotaverine HCl and 1.25 – ϭϴϳ.ϱ μg ŵL -1 for Aceclofenac. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The proposed method was optimized and validated as per the ICH guidelines. Keywords: Drotaverine; Aceclofenac; RP-HPLC-PDA; Method Validation; Column Liquid Chromatography. INTRODUCTION Drotaverine hydrochloride [DRT], 1-[(3, 4-diethoxy phenyl) methylene]-6, 7-diethoxy-1, 2, 3, 4-tetra hydro isoquinolene is an analogue of papaverine [The Merck Index 13 th , 2001]. It acts as an antispasmodic agent by inhibiting phosphodiesterase IV enzyme, specific for smooth muscle spasm and pain, used to reduce exces- sive labor pain [Sethi SD., 2004]. Drotaverine hydroch- loride is official in Polish Pharmacopoeia [Dahivelkar PP et al., 2007]. A few UV spectrophotometric [Dahivelkar PP et al., 2006; Metwally FH et al., 2006; Abdellatif HE et al., 2006] and HPLC [Panigrahi D et al., 2006; Mezei J et al., 1984; Dahivelkar PP et al., 2009] methods have been reported individually or in combination with oth- er drugs for estimation of drotaverine hydrochloride. Aceclofenac [ACE] is chemically designated as 2-(2, 6- Dichloroanalino) phenyl acetoxy acetic acid. It is a NSA- ID, used in the management of osteoarthritis, rheuma- toid arthritis, and ankylosing spondylitis [The Merck Index 13 th , 2001; Martindale 36 th , 2009]. Aceclofenac is official in Indian pharmacopoeia [Indian pharmaco- poeia 2007]. Various UV and HPLC methods for aceclo- fenac have been reported for its estimation individually or in combination with other drugs [Nikam AD et al., 2008; Shah R et al., 2008; Rajmane VS et al., 2009; Momin MY et al., (2006); Musmade P et al., 585 (2007); Hasan NY et al., (2003)]. Authors have developed Ratio Derivative and Area Under Curve Spectrophotometeric methods for the combinations in the same laboratory. To our knowledge there is no HPLC method reported for the combination, availability of HPLC method with high sensitivity and selectivity will be very useful for the estimation of DRT and ACE in combined pharma- ceutical dosage forms. Therefore the aim of the study was to develop a sensitive, precise, accurate and spe- cific HPLC method for the determination of DRT and ACE simultaneously in formulation. The present work describes a simple RP-HPLC PDA method for the de- termination of DRT and ACE in tablets. The method was validated according to ICH guidelines and was found to be reproducible with good resolution be- tween DRT and ACE. EXPERIMENTAL MATERIALS AND REAGENTS Tablets used for analysis were ESNIL manufactured by Dewcare, (Ahmadabad, India) were used for analysis containing DRT 80 mg and ACE 100 mg per tablet. Pure drug sample of DRT (98.5%) and ACE (99.8%) were ob- tained as a gift sample from Alkem Laboratories (Mumbai, India) and Curex pharmaceuticals (Jalgaon, India). HPLC grade Methanol and tetrahydrofuran (THF) were procured from Merck and Qualigens fine Chemicals, respectively (Mumbai, India). Ammonium Acetate and Acetic Acid was procured from Research Lab Fine Chem (Mumbai, India). Double distilled water and tablet placebo was made at lab scale only. www.ijrps.pharmascope.org ISSN: 0975-7538 Research Article * Corresponding Author Email: viraj1404@rediffmail.com Contact: +91-9421081141 Received on: 23-04-2010 Revised on: 15-05-2010 Accepted on: 18-05-2010