Document Type: Short Review Article

Authors

Department of Quality Assurance, Pioneer Pharmacy Degree College, Nr. Ajwa Crossing, Sayajipura, Vadodara, Gujarat, India

Abstract

Method development is the process to prove that the analytical methods employed to measure the concentration of active pharmaceutical drug in a particular compounded dosage form is acceptable. This must be validated to provide accurate data for regulatory submissions. Aceclofenac (ACE) is an analog of diclofenac, a non-steroidal anti-inflammatory drug (NSAIDs). The drug is used in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis ankylosing spondylitis, inflammation and relief of pain. The high importance of this class of drugs has prompted us to review the most important recent spectrophotometric methods for analyzing Aceclofenac in pure formulations, in various types of pharmaceutical dosage and in biological fluids published in the literature to date. They include spectrophotometry, high performance liquid chromatography, high performance thin layer chromatography, liquid chromatography-mass spectrometry, ultra high-performance liquid chromatography, mass spectrometry, and stability indicating methods.High sensitivity, speed, specificity and reproducibility make the use of these conventional methods for acetaminophen detection in routine analysis. They are time consuming, expensive and labour intensive though. Hence future research efforts are presumed to concentrate on developing novel methods to overcome these limitations.

Graphical Abstract

Keywords

[1] Saraf, S., Singh, D., Garg, G., & Saraf, S., (2006). Aceclofenac: A potent non-steroidal anti-inflammatory drug. Pharmaceutical Reviews, 4(3), 119-124.

[2] Dooley, M., Spencer, C., & Dunn, C. (2001). Aceclofenac: A reappraisal of its use in the management of pain and rheumatic disease. Drugs, 61(9), 1351-1378.

[3] Grau, M., Guasch, J., Montero, J., Felipe, A., Carrasco, E., & Julia, S. (1991). Pharmacology of the potent new non-steroidal anti-inflammatory agent aceclofenac. Arzneimittel forschung, 41(12), 1265-1276.

[4] Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission, Ghaziabad, 2018, Vol. II, pp 1143-1145. 

[5] British Pharmacopoeia, Her Mejesty’s Stationery Office, London, 2018, Vol. I, pp 1-49.

[6] European Pharmacopoeia, Council of Europe, Starsbourgcedex: France, 2014, Vol. II, pp 1466-1467.

[7] United State Pharmacopoeia 41 National Formulary 36, The United State     Pharmacopoeial Convection, Rockville, 2018, Vol. II, pp 1400-1401.

[8] William, H., Devi, P., Kurien, J., Valsalakumari, P., & Mohandas, C., (2014). Validated High Performance Thin Layer Chromatographic Estimation of Aceclofenac in Bulkand Pharmaceutical Dosage Forms. IJSR, 3(6), 2613-2617.

[9] Brogden, R. N., & Wiseman, L. R. (1996). Aceclofenac. Drugs52(1), 113-124.

[10] Seth, S.D, & Seth, V. (2009) Textbook of Pharmacololgy

[11] Bushra, R., Muhammad, H.S., Muhammad, I.N., & Aslam, N., (2013). Aceclofenac: ANew Effective and Safe NSAID. IJDDT, 4(1), 34-42.

[12] Drug profile of Aceclofenac, https://pubchem.ncbi.nlm.nih.gov/compound/Aceclofenac.

[13] Drug profile of Aceclofenac, Sep. 2019, https://www.drugbank.ca/drugs/DB06736.

[14] The Merck Index. An Encyclopedia of Chemicals, Drugs & Biological; 14thEdn; Merck Research Laboratories, 2006, p. 22.

[15] Wisher, D. (2012). Martindale: The complete drug reference. Journal of the Medical Library Association100(1), 75-77.

[16] Nasr, J.J., Ashour, A., Eid, M., Elbrashy, A., & Belal, F., (2015). Stability-Indicating Spectrophotometric Determination of Aceclofenac Using Multivariate Calibration. Pharm Anal Acta, 6(3), 1-6.

[17] Srujani, C., Sravanthi, B., & Madhuri, D., (2014). Validated UV Spectrophotometric Methods for the Estimation of Aceclofenac in Bulk and Pharmaceutical Formulation. Sch. Acad. J. Pharm, 3(6), 471-476.

[18] Valambhia, K.R., (2013). Validation of UV spectroscopic method of analysis for assay and dissolution of aceclofenac tablet. World Journal of Pharmacy and Pharmaceutical Sciences, 2(5), 3977-3983.

[19] Susmitha, A., Kalarani, H.D., Venkatesh, P., & Reddy, K.R., (2013). Analytical method development and validation of aceclofenac in pharmaceutical dosage dorm by uv spectroscopy technique. Int J Pharm Pharm Sci, 5(3), 150-153.

[20] Golhar, M.K., Joshi, R.R., Gupta, K.R., & Wadodkar, S.G., (2011). Development and Validation of Spectrophotometric methods for determination of Aceclofenac in Tablets. Int.J. PharmTech Res, 3(2), 787-790.

[21] Bose, A., Dash, P.P., & Sahoo, M.K., (2010). Simple spectrophotometric methods for estimation of aceclofenac from bulk and formulations. Pharmaceutical Methods, 1(1), 57-60.

[22] Shah, R., Magdum, C., Patil, S.K., Chougule, D.K., & Naikwade, N., (2008). Validated Spectroscopic Method for Estimation of Aceclofenac from Table Formulation. Research J. Pharm. and Tech, 1(4), 430-432.

[23] Kalavadiya, B., Joshi, M., Raval, K., Barochiya, K., & Makavana, K., (2013). Development of New Method and Validation for Determination of Aceclofenac in Bulk and Marketed Formulation. International Journal of Pharmaceutical and Chemical Sciences, 2(1), 315-324.

[24] Hinz, B., Auge, D., Rau, T., Reitbrock, S., Brune, K., & Werner, U., (2003). Simultaneous determination of aceclofenac and three of its metabolites in human plasma by high-performance liquid chromatography. Biomed. Chromatogr, 17, 268–275.

[25] Ravisankar, P., Rao, G.D., Sudhakar, S., Devadasu, C.H., Srinivasa, B.P., Sricharitha, P., & Santosh, K.V., (2013). Development and validation of a reverse phase HPLC method for the determination of aceclofenac in bulk and pharmaceutical dosage forms. IJRPC, 3(2), 483-494.

[26] Gupta, C.R., Ratna, J.V., & Younoos, M., (2011). Development and validation of new RP-HPLC method with UV detection for the determination of aceclofenac in plasma. Journal of Pharmacy Research, 4(2), 338-339.

[27] Jat, R.K., Chhipa. R.C., & Sharma, S., (2011). RP-HPLC method for the estimation of aceclofenac in tablet dosage. International Journal of Drug Research and Technology, 1(1), 1-7.

[28] Shah, R.R., Magdum, C.S., & Naikwade, N., (2008). Validated RP-HPLC method for estimation of aceclofenac from bulk and microemulsion formulations. ACAIJ, 7(9), 725-728.

[29] Kanga, W., & Kimb, E.Y., (2008). Simultaneous determination of aceclofenac and its three metabolites in plasma using liquid chromatography–tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis, 46, 587–591.

[30] Reddy, S.R., Naidu, Y.K., Rao, K.D., Ravikiran, V., Rani, Y.S., & Reddy, K.M., (2010). Development and Validation of High-Performance Liquid Chromatography Tandem Mass Spectrometric Method for Quantification of Aceclofenac in Human Plasma. Journal of Pharmacy and Chemistry, 4(3), 89-95.

[31] Bagary, R., Hassan, M.E., ElKady, E.F., & Faten. F., (2014). UPLC-MS/MS Determination of Aceclofenac and Diclofenac in Bulk, Dosage forms and in At-line Monitoring of Aceclofenac Synthesis. British Journal of Pharmaceutical Research, 4(11), 1311-1331.

[32] William, H., Devi, B.P., Kurien, J., Valsalakumari, P.K., & Mohandas, C.K., (2014). Validated High Performance Thin Layer Chromatographic Estimation of Aceclofenac in Bulk and Pharmaceutical Dosage Forms. IJSR, 3(6), 2613-2617.

[33] Basnett, H., Singha, A., Roy, D., & Pradhan, A., (2019). Estimation of paracetamol and aceclofenac in tablets by a novel ratio difference method. RJLBPCS, 5(1), 187-194.

[34] Jeeboia, L., & Boddua, S., (2016). UV spectrophotometric method for simultaneous estimation of Tramadol hydrochloride and Aceclofenac in bulk and tablet dosage form. Int J Pharm Pharm Sci, 8(5), 334-340.

[35] Suryawanshi, S.S., Chaluvaraju, K.C., & Rajani, S., (2016). Development and Validation of UV-Spectrophotometric Method for Simultaneous Estimation of Aceclofenac and Pantoprazole in Bulk and Tablet Dosage Forms Using Hydrotropic Solvent. Ijppr.Human, 6(3), 331-344.

[36] Parmar, A.R., Bhakhar, D.N., Shah, D.K., & Vekariya, K.V., (2012). Simultaneous estimation of Aceclofenac and Serratiopeptidase in Tablet Dosage Form by Absorbance Ratio Method using Visible Spectrophotometry. Der Pharmacia Sinica, 3(3), 321-326.

[37] Gondane, S.J., Deshpande, M.M., Mahajan, M.P., & Sawant, S.D., (2011). Spectrophotometric method development and validation for estimation of Tizanidine and Aceclofenac in Bulk Drug & Tablet formulation. Int.J. ChemTech Res, 3(2), 620-624.

[38] Modak, V.G., Tajane, D.D., Ingale, K.D., Battewar, A.S., Choudhari, V.P., & Kuchekar, B.S., (2011). Spectrophotometric determination of Drotaverine and Aceclofenac in combined tablet dosage form by ratio derivative spectroscopy and area under curve (AUC) spectrophotometric methods. International Journal of Pharmaceutical Sciences Review and Research, 3(1), 111-114.

[39] Suchithra, T.J., & Gurupadayya, B.M., (2018). Simultaneous Estimation of Aceclofenac and Pregabalin in Combined Dosage Form by Solubility Based Separation Method. Acta Scientific Pharmaceutical Sciences, 2(12), 20-26.

[40] Shaikh, K.A., Patil, A.T., & Ingole, A.B., (2012). Sensitive LC method for the simultaneous determination of diacerein and aceclofenac in tablet dosage form. International Journal of Industrial Chemistry, 3(3), 1-7.

[41] Rao, C.M., Rajan, V.S., & Badarinath, A.V., (2011). Simultaneous estimation of Zinc carnosine and Aceclofenac in bulk and tablet dosage form by HPLC method. Int. J. Res. Pharm. Sci., 2(3), 429-433.

[42] Kumar, R.S., Nathan, P.S., Kumar. P.N., & Solomon, W.S., (2010). A validated reversed phase HPLC-method for the determination of Aceclofenac and Tizanidine in tablets. JPRHC, 2(1), 84-94.

[43] Ojha, A., Rathod, R., & Padh, H., (2009). Simultaneous HPLC–UV determination of Rhein and Aceclofenac in human plasma. J. Chromatogr., B, (877), 1145-1148.

[44] Rajamahanti, S.G., Annapurna, N., Santosh, T., Durga, B., & Raziya, S.K., (2017). Evaluation of A New Stability Indicating Method for the Determination of Aceclofenac and Thiocolchicoside in Pharmaceutical Dosage form by RP-HPLC. Orient. J. Chem., 33(3), 1337-1346.

[45] Jawale, A., Kothari, C., Patel, M., & Patel, M., (2017). Novel bio-analytical RP-HPLC method for simultaneous estimation of aceclofenac and drotaverine hydrochloride in human plasma by DOE approach. Ejbps, 4(9), 545-550.

[46] Adhao, V.S., (2016). RP-HPLC Method development and validation for the simultaneous estimation of Aceclofenac and Rabeprazole Sodium in the bulk and marketed formulation. Indian Journal of Pharmacy and Pharmacology, 3(3), 146-151.

[47] Bhavsar, A., Shah, D., Solanki, T., Sevak, N., & Ajmeer, R., (2015). Development and validation of RP- HPLC method for simultaneous estimation of Aceclofenac and Pregabalin in combined tablet dosage form. Pharmaceutical and Biological Evaluations, 2(4), 91-97.

[48] Ventrapragada, B., Kumar, S.A., Debnath, M., Krishna, N.S., & Saravanan, J., (2014) Method development and validation for the simultaneous estimation of aceclofenac and paracetamol in solid dosage form by using RP –HPLC. International Journal of Biopharmaceutics, 5(2), 109-118.

[49] Patel, R.D., Chhalotiya, U.K., Mehta, F.A., Shah, D.A., & Bhatt, K.K., (2014). Liquid Chromatographic Estimation of Cyclobenzaprine Hydrochloride and Aceclofenac in Pharmaceutical Formulation. RRJPPS, 3(3), 37-44.

[50] Gawande, V., Mangaonkar, R., Bothara, K., & Kashid, A., (2013). Validated RP-HPLC method for estimation of Rabeprazole and Aceclofenac from human plasma. Int J Pharm Pharm Sci, 5(4), 381-384.

[51] Manasa, B., & Kumar, A.R., (2012). Development and validation of rp-hplc method for the simultaneous estimation of aceclofenac and rabeprazole sodium in bulk and capsules. IJPBS, 2(3), 160-169.

[52] Chitlange, S.S., Shinde, P.S., Pawbake, G.R., & Wankhede, S.B., (2010). Simultaneous estimation of Thiocolchicoside and Aceclofenac in pharmaceutical dosage form by spectrophotometric and LC method. Der Pharmacia Lettre, 2(2), 86-93.

[53] Baishya, H., Gogoi, B., Bordoloi, R., & Gogoi, P., (2018). A validated reversed phase UHPLC method for simultaneous estimation of aceclofenac and paracetamol in bulk and pharmaceutical dosage form. Asian Journal of Pharmaceutical and Development, 6(2), 1-5.

[54] Khan, H., (2018). Validated UPLC/Q-TOF-MS method for simultaneous determination of aceclofenac and paracetamol in human plasma and its application to pharmacokinetic study. World Journal of Pharmaceutical Research, 7(10), 607-617.

[55] Balan, P., & Kannappan, N., (2014). Development and validation of stability-indicating RP-UPLC method for simultaneous estimation of Thiocolchicoside and Aceclofenac in combined dosage form. International Current Pharmaceutical Journal, 3(7), 296-300.

[56] Patil, A., & Mulla, S., (2013). Development and validation of HPTLC method for the simultaneous estimation of paracetamol and aceclofenac in combined dosage form. Int J Pharm Pharm Sci, 6(1), 641-643.