Open Access Open Access  Restricted Access Subscription or Fee Access

Sensitive Spectrophotometric and Flame Photometric Methods for Determination of Diclofenac Sodium in Pharmaceuticals

Nagaraju Rajendraprasad, Kanakapura Basavaiah

Abstract


Diclofenac sodium (DFS) is a non-steroidal anti-inflammatory drug (NSAID). Two new analytical methods have been developed for the assay of DFS in its pure form, tablets and injections. Spectrophotometric method is based on the oxidation of drug with known excess of cerium(IV) and oxidation of methyl orange (MO) by residual oxidant and measurement of absorbance of unreacted MO at 470 nm. Flame photometric method is based on the measurement of emission radiation of sodium from DFS by flame emission spectrometry. The methods were applicable for quantification of DFS over 1.25–12.5 and 1.0–10.0 µg mL-1 for spectrophotometric and flame photometric method, respectively. The molar absorptivity and Sandell sensitivity values for spectrophotometric method were calculated to be 2.05 × 104 L mol-1 cm-1 and 0.015 µg cm-2, respectively. The limits of detection (LOD) and quantification (LOQ) were 0.2 and 0.62 (Spectrophotometric method) and 0.05 and 0.16 µg mL-1 (Flame photometric method). Intra-day and inter-day precisions were satisfactory with %RSD values of ≤2.11, and the respective accuracies were excellent with %RE values of ≤3. The methods were also validated for robustness, ruggedness and selectivity. The methods were applied to the determination of DFS in its tablets and injections with good accuracy and precision. The results were also compared with those obtained by a reference method. These methods promise the usefulness of them as routine analytical procedures for quantification of DFS in pure form and in dosage forms.

Full Text:

PDF

References


Matin A.A., Farajzadeh M.A., Jouyban A. A simple spectrophotometric method for determination of sodium diclofenac in pharmaceutical formulations, IL Farmaco. 2005; 60: 855–8p. [2] Lala L.G., D’Mello P.M., Naik S.R. HPTLC determination of diclofenac sodium from serum, J Pharm Biomed Anal. 2002; 29: 539–44p. [3] The British Pharmacopoeia, Her Majesty’s Stationery Office, London, 2010, 671–3p. [4] The United States Pharmacopeia, 34th Edn., The National Formulary. 29th Edn., The Official Compendia of Standards, The United States Pharmacopeial Convention, Rockville, MD, 2011, 780–1p. [5] Ulu S.T. New and sensitive spectrofluorimetric method for the determination of non-steroidal antiinflammatory drugs, etodolac and diclofenac sodium in pharmaceutical preparations through derivatization with 7-fluoro-4-nitrobenzo-2-oxa

,3-diazole, J Food Drug Anal. 2011; 19(1): 94–101p. [6] Garcia S., Sanchez P.C., Albero I., et al. Flourimetric and spectrophotometric metod for determination of diclofenac in bulk and pharmaceutical samples, Microchim Acta. 2001; 3: 67–71p. [7] Tubino M., de Souza R.L. Gravimetric method for the determination of diclofenac in pharmaceutical preparations, J AOAC Int. 2005; 88(6): 1684–7p. [8] Szostak R., Mazurek S. Quantification of active ingredients in suppositories by FT-Raman spectroscopy, Drug Test Anal. 2013; 5(2): 126–9p. [9] Fernandez-Llano L., Blanco-Lopez M.C., Lobo-Castanon M.J., et al. Determination of diclofenac in urine samples by molecularly-imprinted solid-phase extraction and adsorptive differential pulse voltammetry, Electroanalysis. 2007; 19(15): 1555– 61p. [10] Yang X., Feng J., Chen Z., et al. Determination of six analgesics by CE with an improved electromagnetic induction detector, Chromatographia. 2012; 75(1-2): 71–6p. [11] El-Kommos M.E., Mohamed N.A., Abdel Hakiem A.F. Selective micellar electrokinetic chromatographic method for simultaneous determination of some pharmaceutical binary mixtures containing non-steroidal antiinflammatory drugs, J Pharm Anal. 2013; 3(1): 53–60p. [12] Yilmaz B. GC–MS determination of diclofenac in human plasma, Chromatographia. 2010; 71(5/6): 549–51p. [13] Ali N., Hegazy M., Abdelkawy M., et al. Simultaneous determination of methocarbamol and its related substance (Guaifenesin) in two ternary mixtures with ibuprofen and diclofenac potassium by HPTLC spectrodensitometric method, J Planar Chromatogr-Modern TLC. 2012; 25(2): 150–5p.

Emara L.H., Taha N.F., El-Ashmawy A.A., et al. A rapid and sensitive bioanalytical HPLC method for determining diclofenac sodium in human plasma for bioequivalence studies, J Liquid Chromatogr Relat Technol. 2012; 35(15): 2203–16p. [15] Chmielewska A., Konieczna L., Plenis A., et al. Determination of diclofenac in plasma by highperformance liquid chromatography with electrochemical detection, Biomed Chromatogr. 2006; 20(1): 119–24p. [16] Abdel-Hamid M.E., Novotny L., Hamza H. Determination of diclofenac sodium, flufenamic acid, indomethacin and ketoprofen by LCAPCI-MS, J Pharm Biomed Anal. 2001; 24(4): 587–94p. [17] Mitic S., Miletic G., Pavlovic A., et al. Determination of diclofenac sodium in commercial pharmaceutical formulations and human control serum using a kineticspectrophotometric method, Chem Pharm Bull. 2007; 55(10): 1423–6p. [18] Cantarelli M.A., Pellerano R.G., Marchevsky E.J., et al. Simultaneous determination of amoxicillin and diclofenac in pharmaceutical formulations using uv spectral data and the PLS chemometric method, Anal Sci. 2011; 27(1): 73–8p. [19] Patel A., Patel J., Shah A. Development and validation of first order derivative spectrophotometric method for simultaneous estimation of tramadol hydrochloride and diclofenac sodium in tablet dosage form, Int J Pharm Pharm Sci. 2012; 4: 496–500p. [20] El-Didamony A.M., Amin A.S. Adaptation of a color reaction for

spectrophotometric determination of diclofenac sodium and piroxicam in pure form and in pharmaceutical formulations, Anal Lett. 2011; 37(6): 1151–62p. [21] Kormosh Zh.O., Hunka I.P., Bazel Ya R. Extraction and spectrophotometric determination of diclofenac in pharmaceuticals, J Chin Chem Soc. 2008; 55(2): 356– 61p. [22] Joshi R., Gupta K. Simultaneous UV-spectrophotometric determination of thiocolchicoside and diclofenac in pharmaceutical formulation, Der Pharm Sin. 2010; 1: 44–51p. [23] Szuitowaska M., Stokrocka M. Determination of diclofenac released from suppositories using UV spectrophotometry, spectra derivative spectrophotometry and HPLC, Acta Pol Pharm-Drug Res. 2007; 63: 401–5p. [24] Sena M.M., Chaudhry Z.F., Colling C.H., et al. Direct determination of diclofenac in pharmaceutical formulations containing B vitamins by using UV spectrophotometry and partial least squares regression, J Pharm Biomed Anal. 2004; 36: 743– 9p. [25] Botello J.C., Caballera G.P. Spectrophotometric determination of diclofenac sodium with methylene blue, Talanta. 1995; 42: 105–8p. [26] Idowu O.S., Adegoke O.A., Oderin B.A., et al. Rapid colorimetric assay of diclofenac sodium tablets using 4carboxyl-2, 6-dinitrobenzene diazonium ion (CDNBD), Pak J Pharm Sci. 2006; 19: 141–8p. [27] Souza R., Tubion M. Spectrophotometric determination of diclofenac in pharmaceutical preparations, J Braz Chem Soc. 2005; 16: 1068p.

Belal T.S., Mahrous M.S., AbdelKhalek M.M., et al. Application of a new simple spectrophotometric method to the simultaneous determination of diclofenac sodium and diflunisal in their combined dosage form, Res J Pharm Biol Chem Sci. 2014; 5(2): 552–63p. [29] Pandey G. Spectrophotometric methods for estimation of diclofenac sodium in tablets, Int J Biomed Adv Res. 2013; 4(2): 77–82p. [30] International Conference on Hormonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite

Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R 1), Complementary Guideline on Methodology dated 06 November 1996, incorporated in November 2005, London. [31] Basset J., Denney R.C., Jeffrey G.H., et al. Vogel’s Textbook of Quantitative Analysis. 4th Edn., Longman Group Limited; 1978; 598p. [32] Burrows A., Holman J., Parsons A., et al. Text Book of “Chemistry: Introducing Inorganic, Organic and Physical Chemistry. 1st Edn, 2009, 546p.


Refbacks

  • There are currently no refbacks.