Validated Stability-Indicating Assay Method for Simultaneous Determination of Aceclofenac and Thiocolchicoside using RP-HPLC

Abstract

A rapid, accurate, precise, robust and specific stability indicating RP-HPLC method has been developed and validated for simultaneous determination of fixed dose combination of Aceclofenac (ACF) and Thiocolchicoside (THC). Combinations and marketed tablets were subjected to stress conditions such as oxidation, hydrolysis, photolysis and heat. Successful separation of drugs from stress degradation products was achieved on Kromasil C18 (250×4.6 mm, 5 μm) column at 30°C using gradient mobile phase system consisting of (A) 10 mM ammonium acetate pH 5.00 buffer and (B) acetonitrile: water (70:30 v/v). The flow rate was 1.0 mL/min with UV detection at 265 nm. The retention time of THC and ACF was 13.29 and 22.20 min respectively. Peak purity of both the drugs was passing in all degradation conditions demonstrates the specificity of assay method for their estimation in presence of degradation products. The developed HPLC method was validated for linearity, accuracy, precision and robustness. The linearity of the proposed method was investigated in the range of 80–280 µg/mL for ACF and 6.4–22.4 µg/mL for THC. The utility of the procedure was verified by its application to marketed formulations.

Key words

Thiocolchicoside - Aceclofenac - stability-indicating assay method - RP-HPLC

• References

• 1 Janbroers JM. Review of the toxicology, pharmacodynamics and pharmacokineticss of thiocolchicoside, a GABA-agonist muscle relaxant with anti-inflammatory and analgesic actions. Acta therapeutica 1987; 13: 221-250
• 2 Aksoy C, Karan A, Diracoglu D. Low back pain: results of an open clinical trial comparing the standard treatment alone to the combination of standard treatment and thiocolchicoside. Journal of Orthopaedics and Traumatology 2002; 3: 103-108
• 3 Guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Stability Testing of New Drug Substances and Products, Q1(R2), Step 4 2003; 1-17
• 4 The United States Pharmacopoeia 26^th ed. US Pharmacopoeial Convention; Rockville, MD: 2003: 1151
• 5 Bhinge JR, Kumar RV, Sinha VR. A simple and sensitive stability-indicating RP-HPLC assay method for the determination of aceclofenac. Journal of chromatographic science 2008; 46: 440-444
• 6 Zawilla NH, Abdul Azim Mohammad M, El Kousy NM et al. Determination of aceclofenac in bulk and pharmaceutical formulations. Journal of pharmaceutical and biomedical analysis 2002; 27: 243-251
• 7 Azhlwar S, Ravi TK. Simultaneous densitometric analysis of drotaverine and aceclofenac by HPTLC method. Der Pharmacia Lettre 2010; 2: 328-332
• 8 Chitlange SS, Shinde PS, Pawbake GR et al. Simultaneous estimation of Thiocolchicoside and Aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Der Pharmacia Lettre 2010; 2: 86-93
• 9 Choudhari V, Ingale K, Sahoo M et al. Development and validation of a RP-HPLC-PDA method for simultaneous estimation of Drotaverine and Aceclofenac in a combined dosage form. Int J Res Pharm Sci 2010; 1: 253-258
• 10 Garg G, Saraf S. Simultaneous estimation of aceclofenac, paracetamol and chlorzoxazone in tablets. Indian journal of pharmaceutical sciences 2007; 69: 692-694
• 11 Gharge D, Dhabale P. Simultaneous Estimation of Aceclofenac and Paracetamol in Solid Dosage Form by RP-HPLC Method. Int J ChemTech Res 2010; 2: 942-946
• 12 Godse VP, Deodhar MN, Bhosale AV et al. Reverse phase HPLC method for determination of Aceclofenac and Paracetamol in tablet dosage form. Asian J Research Chem 2009; 2: 37-40
• 13 Gopinath R, Rajan S, Meyyanathan SN et al. RP-HPLC method for simultaneous estimation of paracetamol and aceclofenac in tablets. Indian journal of pharmaceutical sciences 2007; 69: 137-140
• 14 Jadhav SD, Butle SR, Patil SD et al. Validated stability indicating RP-HPLC method for simultaneous determination and in vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arabian Journal of Chemistry 2011; article in press
• 15 Joshi R, Sharma R. Development and validation of RP-HPLC method for simultaneous estimation of three-component tablet formulation containing acetaminophen, chlorzoxazone, and aceclofenac. Analytical Letters 2008; 41: 3297-3308
• 16 Kachhadia PK, Doshi AS, Ram VR et al. Validated LC method for simultaneous analysis of tramadol hydrochloride and aceclofenac in a commercial tablet. Chromatographia 2008; 68: 997-1001
• 17 Kumar RS, Nathan PS, Nallasivan PK et al. Validated RP-HPLC method for the simultaneous estimation of aceclofenac and diacerein in bulk and formulation. Int J Pharm Tech Res 2010; 2: 945
• 18 Marolia BP, Vanparia DJ, Satani BH et al. Application of RP-HPLC Method for Simultaneous Estimation of Thiocolchicoside and Diclofenac in Commercially Available Capsules. American Journal of PharmTech Research 2012; 2: 806-817
• 19 Momin MY, Yeole PG, Puranik MP et al. Reverse phase HPLC method for determination of aceclofenac and paracetamol in tablet dosage form. Indian journal of pharmaceutical sciences 2006; 68: 387
• 20 Sahoo M, Syal P, Ingale S et al. Development and Validation of a RP-HPLC-PDA method for Simultaneous Determination of Lornoxicam and Thiocolchicoside in Pharmaceutical dosage form and its Application for Dissolution study. Int J Res Pharm Sci 2011; 2: 1-7
• 21 Shaikh KA, Devkhile AB. Simultaneous determination of aceclofenac, paracetamol, and chlorzoxazone by RP-HPLC in pharmaceutical dosage form. Journal of chromatographic science 2008; 46: 649-652
• 22 Wankhede SB, Zambare SS, Dixit NR et al. RP-HPLC Method for Simultaneous Estimation of Thiocolchicoside and Ketoprofen in Combined Dosage Form. Der Pharmacia Lettre 2010; 2: 315-320