• M. S. SWARNA PUSHPA Department of Chemistry, NRI Institute of Technology, Agiripalli, Andhra Pradesh, India
  • T. RAJA RAJESWARI Principal, Government Degree College, Eluru, Andhra Pradesh, India




Etoricoxib, Pregabalin, Fixed dose formulation, RP-HPLC, Stability testing


Objective: This evaluation study aims to initiate a relatively sensitive RP-HPLC quantifiable technique for evaluating pregabalin (PRBN) and etoricoxib (ETRB) combination in tablet and bulk kinds.

Methods: PRBN and ETRB chromatographic evaluations were carried off using the “KNAUER C18 Eurospher II column (250 mm × 4.6 mm × 5 μ)”. The mobile phase (MBP) was driven into the KNAUER C18 Eurospher II column at a 1.0 ml/min run rate with an isocratic elution programme of 65% volume of 0.5 mmol sodium perchlorate 35% volume methanol, detected and evaluated the PRBN and ETRB content at 217 nm.

Results: The analysis of PRBN and ETRB is executed inside a run period of 15 min. The RP-HPLC quantifiable technique was developed to separate PRBN and ETRB and likely degradants formed from stress testing by isocratic elution. The RP-HPLC quantifiable technique developed was successfully validated to existing ICH limit guidelines and was confirmed as robust, specific, accurate, selective, precise, sensitive, and linear.

Conclusion: The RP-HPLC quantifiable technique developed here is more valuable and worthy for routine PRBN and ETRB analysis of tablets and bulk kinds.


Download data is not yet available.


Brooks P, Kubler P. Etoricoxib for arthritis and pain management. Ther Clin Risk Manag. 2006;2(1):45-57. PMID 18360581.

Pore Y, Mane M, Mangrule V, Chopade A, Gajare P. Preparation, characterization, and evaluation of the anti-inflammatory activity of etoricoxib loaded soluplus® nanocomposites. Int J App Pharm. 2018;10(6):268-74. doi: 10.22159/ijap.2018v10i6.26042.

Zhang S, Zhang Y, Liu P, Zhang W, Ma JL, Wang J. Efficacy and safety of etoricoxib compared with NSAIDs in acute gout: a systematic review and a meta-analysis. Clin Rheumatol. 2016;35(1):151-8. doi: 10.1007/s10067-015-2991-1, PMID 26099603.

Timur UT, Caron MMJ, Jeuken RM, Bastiaansen-Jenniskens YM, Welting TJM, van Rhijn LW, van Osch GJVM, Emans PJ. Chondroprotective actions of selective COX-2 inhibitors in vivo: A systematic review. Int J Mol Sci. 2020;21(18):6962. doi: 10.3390/ijms21186962, PMID 32971951.

Toth C. Pregabalin: latest safety evidence and clinical implications for the management of neuropathic pain. Ther Adv Drug Saf. 2014;5(1):38-56. doi: 10.1177/2042098613505614, PMID 25083261.

Derry S, Bell RF, Straube S, Wiffen PJ, Aldington D, Moore RA. Pregabalin for neuropathic pain in adults. Cochrane Database Syst Rev. 2019;1:CD007076. doi: 10.1002/14651858.CD007076.pub3, PMID 30673120.

Khajuria K, Gupta S, Dogra DR, Kumar D, Khajuria V. Comparison of pregabalin and nortriptyline on efficacy and safety in postherpetic neuralgia. Asian J Pharm Clin Res. 2021;14:74-6.

Verma V, Singh N, Singh Jaggi A. Pregabalin in neuropathic pain: evidences and possible mechanisms. Curr Neuropharmacol. 2014;12(1):44-56. doi: 10.2174/1570159X1201140117162802, PMID 24533015.

Gupta YK, Ramachandran SS. Fixed-dose drug combinations: issues and challenges in India. Indian J Pharmacol. 2016;48(4):347-9. doi: 10.4103/0253-7613.186200, PMID 27756941.

A clinical trial to study the efficacy and safety of combination drugs of pregabalin prolonged release and etoricoxib in comparison to single therapy of etoricoxib in patients having chronic low back pain in India. Cochrane Library, Available from: https://www.cochranelibrary.com/content?urlTitle=%2Fcentral%2Fdoi%2F10.1002%2Fcentral%2FCN-01904940anddoi=10.1002%2Fcentral%2FCN-01904940andp_p_id= scolariscontentdisplay_WAR_scolariscontentdisplayand_scolariscontentdisplay _WAR_scolariscontentdisplay_action=central-referencesandp_p_ lifecycle=0andp_p_mode=viewandtype=centralandcontentLanguage=. [Last accessed on 20 Jun 2021]

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

Rode DM, Rao NN. A review on development and validation of stability-indicating HPLC methods for analysis of acidic drugs. Int J Curr Pharm Sci. 2019;11:22-33. doi: 10.22159/ijcpr.2019v11i4.34939.

International Conference on Harmonization (ICH). Harmonized tripartite guideline validation of analytical procedures: text and methodology Q2. Vol. R1. Geneva: IFPMA. Switzerland; 2005.

Ravichandran V, Shalini S, Sundaram KM, Rajak H. Validation of analytical methods-strategies and importance. Int J Pharm Pharm Sci. 2010;2:18-22.

de Souza SVC, Junqueira RG. A procedure to assess linearity by ordinary least squares method. Anal Chim Acta. 2005;552(1-2):25-35. doi: 10.1016/j.aca.2005.07.043.

Sanagi MM, Nasir Z, Ling SL, Hermawan D, Ibrahim WA, Naim AA. A practical approach for linearity assessment of calibration curves under the International Union of Pure and Applied Chemistry (IUPAC) guidelines for in-house validation of method of analysis. J AOAC Int. 2010;93(4):1322-30. doi: 10.1093/jaoac/93.4.1322, PMID 20922968.

Sanagi MM, Ling SL, Nasir Z, Hermawan D, Ibrahim WA, Abu Naim A. Comparison of signal-to-noise, blank determination, and linear regression methods for the estimation of detection and quantification limits for volatile organic compounds by gas chromatography. J AOAC Int. 2009;92(6):1833-8. doi: 10.1093/jaoac/92.6.1833, PMID 20166602.

Horwitz W, Albert R. The horwitz ratio (HorRat): A useful index of method performance with respect to precision. J AOAC Int. 2006;89(4):1095-109. doi: 10.1093/jaoac/89.4.1095, PMID 16915851.

Furey A. Method validation: A complex concept. Pharm Methods. 2011;2(1):1-2. doi: 10.4103/2229-4708.81081, PMID 23781421.

Ammann C. Stability studies are needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products. AAPS PharmSciTech. 2011;12(4):1264-75. doi: 10.1208/s12249-011-9684-0, PMID 21948319.

Pandya CP, Rajput SJ. Development and validation of stability-indicating method RP-HPLC method of acotiamide. Int J Pharm Pharm Sci. 2018;10(9):1-8. doi: 10.22159/ijpps.2018v10i9.24925.



How to Cite

PUSHPA, M. S. S., & RAJESWARI, T. R. (2021). RP-HPLC QUANTIFIABLE TECHNIQUE DEVELOPMENT FOR EVALUATING PREGABALIN AND ETORICOXIB COMBINATION IN TABLET AND BULK KINDS. International Journal of Applied Pharmaceutics, 13(6), 152–156. https://doi.org/10.22159/ijap.2021v13i6.42759



Original Article(s)