Simultaneous Determination of Flurbiprofen and Thiocolchicoside in Pharmaceutical Preparations by a Validated HPLC Method

Simultaneous Determination of Flurbiprofen and Thiocolchicoside in Pharmaceutical Preparations by a Validated HPLC Method

In this study, a new high performance liquid chromatography (HPLC) analysis method was developed for the simultaneous determination of flurbiprofen (F) and thiocolchicoside (T) in pharmaceutical products. A C18 column (Agilent Poroshell 120 EC-C18) was used as the stationary phase. Elution of the analytes was achieved by using gradient elution system. Mobile phase A was an acetate buffer (100 mM, pH 4.8) and mobile phase B was acetonitrile. The flow rate for the method developed was 0.5 ml/min. The temperature of the column compartment was set at 40°C and the injection volume was 5 μl. Monitoring of the analytes was carried out at 248 nm. The method was found linear in the concentration range between 5-100 ppm. The correlation coefficient value was calculated as 0.999 for F and 0.999 for T. The method was found suitable in terms of accuracy, precision, specificity, linearity, and robustness ruggedness. Furthermore, it was applied successfully for the analysis of commercial tablets and gel samples that contains F and T without any time-consuming pre-procedure. The recovery values for Fand T were found as 99.5% and 97.0% in tablet formulations and 98.6% and 99.3% in gel formulations, respectively. All results were acceptable and this confirmed that the method is suitable for its intended use in routine quality control and an assay of drugs.

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  • [1] Murali Mohan Babu G.V, Prasad CDS, Hima Sankar K, Gouri Sankar V, Kishore Kumar N, Ramana Murthy KV. Development of new controlled release formulation of flurbiprofen: in vitro –in vivo correlation. Indian J Pharm Sci. 2002; 64: 37 –43.
  • [2] Kagkadis KA, Rekkas M, Dallas PP, Choulis NH. A freeze-dried injectable form of flurbiprofen: development and optimization using response surface methodology; Int J Pharm. 1998; 161: 87 –94. [Cross Ref]
  • [3] Muraoka A, Tokumura T, Machida Y. Evaluation of the bioavailability of flurbiprofen and its β-cyclodextrin inclusion complex in four different doses upon oral administration to rats. The Eur J Pharm Biopharm. 2004; 58: 667–671. [Cross Ref]
  • [4] Poul J, West J, Buchanan N, Grahame R. Local action transcutaneous flurbiprofen in the treatment of soft tissue rheumatism. Br J Rheumatol. 1993; 32: 1000–1003. [Cross Ref]
  • [5] Jana S, Shekhawat GS. Critical review on medicinally potent plant species: Gloriosa superb. Fitoterapia. 2011; 82(3): 293- 301. [Cross Ref]
  • [6] Janbroers JM. Review of the toxicology, pharmacodynamics and pharmacokinetics of Tiocolchicosoid, a GABA-agonist muscle relaxant with anti-inflammatory and analgesic actions. Acta Ther. 1987; 13: 221-227. [Cross Ref]
  • [7] Trellu M, Filali-Ansary A, Françon D, Adam R, Lluel P, Dubruc C, Thénot JP. New metabolic and pharmacokinetic characteristics of thiocolchicoside and its active metabolite in healthy humans. Fundam Clin Pharmacol. 2004; 18(4): 493- 501. [Cross Ref]
  • [8] Yılmaz B, Alkan E. Spectrofluorometric and UV spectrophotometric methods for the determination of flurbiprofen in pharmaceutical preparations. Res Rev Pharm Anal. 2015; 4(4).
  • [9] Mathew C, Mala N, Makula A, Puvvad SB. A Green Approach for the Simultaneous Estimation of Gatifloxacin and Flurbiprofen by a Very Sensitive Spectrofluorimetric Method. IOSR J Pharm Biol Sci. 2016; 11(1): 60-66.
  • [10] Chandran S, Jadhav PR, Kharwade PB, Saha RN. Rapid and sensitive spectrofluorimetric method for the estimation of selecoxib and flurbiprofen. Indian J Pharm Sci. 2006; 68 (1):20-25.
  • [11] Akhlaq M, Khan GM, Wahab A, Khan A, Hussain A, Nawaz A, Abdelkader H. A simple high-performance liquid chromatographic practical approach for determination of flurbiprofen. J Adv Pharm Technol Res. 2011; 2(3): 151-155. [Cross Ref]
  • [12] Işık BD, Acar ET. Development and Validation of an HPLC Method for the Simultaneous Determination of Flurbiprofen and Chlorhexidine Gluconate. Chromatographia. 2018; 81:699–706.
  • [13] Aminu N, Chan SY, Toh SM. Development and validation of a stability-indicating HPLC-UV method for the simultaneous determination of flurbiprofen and triclosan in dental nanogel formulations. J.Phys. Sci. 2018; 29(1): 1– 7. [Cross Ref]
  • [14] Yilmaz B, Erdem AL, Determination of Flurbiprofen in Human Plasma by High-Performance Liquid Chromatography. J Chromatoger Sci. 2015; 53(9): 1443–1448. [Cross Ref]
  • [15] Hassan M, Alshana U. Switchable-hydrophilicity solvent liquid–liquid microextraction of non-steroidal antiinflammatory drugs from biological fluids prior to HPLC-DAD determination. J Pharm Biomed Anal. 2019; 174: 509– 517. [Cross Ref]
  • [16] Mei C, Li B, Yin Q, Jin J, Xiong T, He W, Gao X, Xu R, Zhou P, Zheng H, Chen H. Liquid chromatography-tandem mass spectrometry for the quantification of flurbiprofen in human plasma and its application in a study of bioequivalence. J Chromatogr B. 2015; 994: 69-74. [Cross Ref]
  • [17] Yılmaz B, Alkan E. Determination of flurbiprofen in pharmaceutical preparations by GC-MS. Arab J Chem. 2019; 12(8): 2077-2083. [Cross Ref]
  • [18] Hamoudová R, Pospísilová M. Determination of ibuprofen and flurbiprofen in pharmaceuticals by capillary zone electrophoresis. J Pharm Biomed Anal. 2006; 41: 1463-1467. [Cross Ref]
  • [19] Rele RV. UV-spectrophotometric estimation of thiocolchicoside by derivative method in pharmaceutical dosage form. Der Pharmacia Lettre. 2015; 7(7):221-226.
  • [20] Acharjya SK, Mallick P, Panda P, Annapurna MM. Spectrophotometric methods for the determination of thiocolchicoside in bulk and pharmaceutical dosage form. J Pharm Edu Res. 2010; 1(1): 51- 7. [Cross Ref]
  • [21] Bhavsar A, Joshi T, Vikani K, Senta A. Development and validation of UV-Visible spectrophotometric method for simultaneous estimation of ketoprofen and thiocolchicoside in solid oral dosage form. Int Res J Pharm. 2016; 7 (5): 53-58. [Cross Ref]
  • [22] Aprile S, Canavesi R, Bianchi M, Grosa G, Del Grosso E. Development and validation of a stability-indicating HPLCUV method for the determination of thiocolchicoside and its degradation products. J Pharm Biomed Anal. 2017; 132: 66-71. [Cross Ref]
  • [23] Jadhav SD, Butle SR, Patil SD, Jagtap PK. Validated stability indicating RP-HPLC method for simultaneous determination and in vitro dissolution studies of thiocolchicoside and diclofenac potassium from tablet dosage form. Arab J Chem. 2015; 8(1): 118-28. [Cross Ref]
  • [24] Sahoo M, Syal P, Ingale S, Ingale K, Sindhe S, Sali M, Choudhari VP, Bhanudas K. Development and Validation of a RP-HPLC-PDA method for Simultaneous Determination of Lornoxicam and Thiocolchicoside in
  • [25] Walash M, Belal F, Eid M, El Abass SA. Simultaneous HPLC determination of thiocolchicoside and glafenine as well as thiocolchicoside and floctafenine in their combined dosage forms. J Chromatogr Sci. 2011; 49(2): 159-64. [Cross Ref]
  • [26] Kumar S, Joshi A, Thakur RS, Pathak AK, Shah K. Simultaneous estimation of etoricoxib and thiocolchicoside by RPHPLC method in combined dosage forms. Acta Pol Pharm. 2011; 68(6): 839-45.
  • [27] Dhiware AD, Gandhi SV, Deshpande PB, Bhavnani VS. A simple and sensitive RP-HPLC method for simultaneous estimation of etodolac and thiocolchicoside in combined tablet dosage form. Int J Pharm Sci. 2012; 4(4): 214-6.
  • [28] Wankhede SB, Zambare SS, Dixit NR, Chitlange SS. RP-HPLC method for simultaneous estimation of thiocolchicoside and ketoprofen in combined dosage form. Pharm Let. 2010; 2(3): 315-320.
  • [29] El-Ragehy NA, Ellaithy MM, El-Ghobashy MA. Determination of thiocolchicoside in its binary mixtures (thiocolchicoside–glafenine and thiocolchicoside–floctafenine) by TLC–densitometry. Farmaco. 2003; 58(6): 463-8. [Cross Ref]
  • [30] United States Pharmacopoeial Convention, Validation of Compendial Procedures, in United States Pharmacopoeia, United States Pharmacopoeial Convention: Rockville. 2016. p. 1640-1645.
Journal of research in pharmacy (online)-Cover
  • Yayın Aralığı: Yılda 6 Sayı
  • Yayıncı: Marmara Üniversitesi
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