Research Journal of Pharmacy and Technology

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A New Stability Indicating Rp-uflc Method for the Estimation Of Etoricoxib in Pharmaceutical Dosage Forms


Affiliations
1 Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra pradesh-530045,, India
     

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Etoricoxib is a selective COX-2 inhibitor and used as a non-steroidal anti-inflammatory drug. A new validated stability indicating RP-UFLC method has been developed for the estimation of Etoricoxib in pharmaceutical dosage forms (Tablets). Shimadzu UFLC system (PDA detector) with Agilent C18 column was chosen for the chromatographic study with mobile phase Acetonitrile: water (50: 50) and flow rate 0.8 mL/min (UV detection at 230 nm). Beer-Lambert’s law was obeyed over a concentration range 0.1-100 μg/mL. The linear regression equation was found to be y = 82642x -13032 (R2 = 0.9998). The LOD and LOQ was found to be and 0.0291 and 0.0894 μg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Etoricoxib formulations.

Keywords

Etoricoxib, RP-UFLC, Stability indicating, Validation, ICH guidelines.
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  • Matsumoto AK, Melian A, Mandel DR, McIlwain HH, Borenstein D, Zhao PL, Lines CR, Gertz BJ, Curtis S. Etoricoxib Rheumatoid Arthritis Study Group. A randomized, controlled, clinical trial of Etoricoxib in the treatment of rheumatoid arthritis. Journal of Rheumatology. 2002; 29 (8): 1623-1630.

  • Duncan MR and Capell HA. Etoricoxib in the treatment of chronic pain. International Journal of Clinical Practice. 2003; 57(4): 315- 318.

  • Leclercq P and Malaise MG. Etoricoxib. (Arcoxia). Rev Med Liege. 2004; 59(5): 345-349. 4. Cochrane DJ, Jarvis B, Keating GM. Etoricoxib. Drugs. 2002; 62(18): 2637-2651.

  • Gourab Maheshwari, Ganesa Sundararajan Subramanian, Arumugam Karthik, Ranjithkumar A, Prashant Musmade, Kishore G and Nayanabhirama Udupa. High-performance thin-layer chromatographic determination of Etoricoxib in the bulk drug and in pharmaceutical dosage form. Journal of Planar Chromatography 20.5 (2007): 335-339.

  • Xiaoran Zhang, Nan Guo,Wei Ji and Qing Wen. Rapid quantitative analysis of Etoricoxib in human plasma by UPLC‐MS/MS and application to a pharmacokinetic study in Chinese healthy volunteers. Biomedical chromatography 33.2 (2019): e4414

  • Sérgio Luiz Dalmora, Liberato Brum Junior, Ricardo Machado Ferretto, Paulo Renato de Oliveira, Thiago Barth and Maximiliano da Silva Sangoi. Determination of Etoricoxib in human plasma using automated on-line solid-phase extraction coupled with LCAPCI/ MS/MS. Quim. Nova 31.3 (2008): 574-578.

  • Liberato Brum Junior, Danieli Cátia Ceni, Marcio Fronza, Paulo Renato de Oliveira and Sérgio Luiz Dalmora. Validation of an LC‐Tandem MS/MS method for the determination of Etoricoxib in human plasma and pharmaceutical formulations. Journal of Liquid Chromatography and Related Technologies. 2006; 29(1): 123-135.

  • Manish Kumar Thimmaraju, Venkat Rao, Hemanth. K, Siddartha P. RP HPLC method for the determination of Etoricoxib in bulk and pharmaceutical formulations. Der Pharmacia Lettre. 2011; 3(5): 224-231.

  • Ashok KS and Nooman AK. High performance liquid chromatographic determination of Etoricoxib in human plasma. Asian Journal of Chemistry. 2007; 19(7): 5241-5250.

  • Gangane PS, Bagde SM,Mujbaile SG and K.D.Niranjane. Development and validation of HPLC assay method for Etoricoxib in bulk drug and tablet formulation. Indian Journal of Natural Sciences 2014; 4(24): 1565-1572.

  • Patel HM, B. N. Suhagia, S. A. Shah and I. S. Rathod. Determination of Etoricoxib in pharmaceutical formulations by HPLC method. Indian Journal of Pharmaceutical Sciences. 2012; 69(5): 703-705.

  • Muhammad Alzweiri., et al. Mariam Sallam, Walid Al-Zyoud and Khaled Aiedeh. Stability study of Etoricoxib a selectivecyclooxygenase-2 inhibitor by a new single and rapid reversed phase HPLC method. Symmetry. 2018; 10(288): 1-12.

  • Srinivasu Topalli, Chandrashekhar TG and Mathrusri Annapurna M. Validated RP- HPLC method for the assay of Etoricoxib (a non-steroidal anti-inflammatory drug) in pharmaceutical dosage forms. E-Journal of Chemistry. 2012; 9(2) : 832-838.

  • Manish Kumar Thimmaraju, Venkat Rao, Hemanth K and Siddartha.K. Determination of Etoricoxib in bulk and pharmaceutical dosage forms by UV spectrophotometric method. International Journal of Pharm Tech Research. 2012; 4(2): 860- 865.

  • Shahi SR, Agrawal GR, Rathi PB, Shinde NV, Somani VG, Mahamuni SB and Padalkar AN. Development and validation of UV spectrophotometric method for the determination of Etoricoxib in bulk and tablet formulation. Rasayan Journal of Chemistry. 2008; 1(2): 390-394.

  • Garlapati Manideep, Nazare Lobo John Shane, Girish Pai, Muddukrishna Badamane Sathyanarayana. Development and validation of a UV spectroscopic method to estimate Etoricoxib in bulk and tablet formulation. Research Journal of Pharmacy and Technology. 2018; 11(2): 758-760.

  • Juyal V, M.Chaudhary, Kumar P, Gnanarajan G. Development and validation of spectrophotometric method for estimation of Etoricoxib in tablet dosage forms. Journal of pharmacy research. 2009; 2(2): 200-202.

  • Singh S, Mishra A, Verma A, Ghosh AK, Mishra AK. A simple ultraviolet spectrophotometric method for the determination of Etoricoxib in dosage formulations. Journal of Advanced Pharmaceutical Technology and Research. 2012; 3(4): 237-240.

  • Sérgio Luiz Dalmora,Maximiliano da Silva Sangoi,Lucélia Magalhães da Silva,Rui Oliveira Macedo,Thiago Barth. Validation of a capillary zone electrophoresis method for the comparative determination of Etoricoxib in pharmaceutical formulations. Journal of Separation Science. 2008; 31(1): 169- 176.

  • Amar Srikar B and Mukthinuthalapati Mathrusri Annapurna. A Review on the Analytical Techniques for the Quantification of Etoricoxib. Acta Scientific Pharmaceutical Sciences. 2021; 5(6): 82-85.

  • ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).

  • ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).


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  • A New Stability Indicating Rp-uflc Method for the Estimation Of Etoricoxib in Pharmaceutical Dosage Forms

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Authors

Sai Gnaneswari Aluri
Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra pradesh-530045,, India
Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management (Deemed to be University), GITAM School of Pharmacy, Visakhapatnam, Andhra pradesh-530045,, India

Abstract


Etoricoxib is a selective COX-2 inhibitor and used as a non-steroidal anti-inflammatory drug. A new validated stability indicating RP-UFLC method has been developed for the estimation of Etoricoxib in pharmaceutical dosage forms (Tablets). Shimadzu UFLC system (PDA detector) with Agilent C18 column was chosen for the chromatographic study with mobile phase Acetonitrile: water (50: 50) and flow rate 0.8 mL/min (UV detection at 230 nm). Beer-Lambert’s law was obeyed over a concentration range 0.1-100 μg/mL. The linear regression equation was found to be y = 82642x -13032 (R2 = 0.9998). The LOD and LOQ was found to be and 0.0291 and 0.0894 μg/mL respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. The proposed method is simple, precise, accurate and robust and can be applied for the quantification of Etoricoxib formulations.

Keywords


Etoricoxib, RP-UFLC, Stability indicating, Validation, ICH guidelines.

References