A NOVEL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF NEFOPAM HYDROCHLORIDE IN PARENTERAL DOSAGE FORM BY RP-HPLC METHOD

CH. NEELIMA; M. HEMASRI; P. SUSMITHA; S. SRILAKSHMI

doi:10.22159/ijcpr.2022v14i4.1982

Authors

CH. NEELIMA School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada 533003, Andhra Pradesh, India
M. HEMASRI School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada 533003, Andhra Pradesh, India
P. SUSMITHA School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada 533003, Andhra Pradesh, India
S. SRILAKSHMI School of Pharmaceutical Sciences and Technologies, Jawaharlal Nehru Technological University Kakinada, Kakinada 533003, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijcpr.2022v14i4.1982

Keywords:

Nefopam hydrochloride, RP-HPLC, Method development, Forced degradation studies

Abstract

Objective: Using RP-HPLC, a simple, accurate, and exact method for estimating the Nefopam Hydrochloride parenteral dose form was devised.

Methods: The isocratic mode of the RP-HPLC method used an Inertsil C₈ column as the stationary phase and a mobile phase of potassium dihydrogen phosphate with pH 3.0: Acetonitrile (70:30) at a flow rate of 1 ml/min. With UV detection at 220 nm, a flow rate of 1 ml/min was established.

Results: The developed RP-HPLC technique revealed acceptable linearity (R2 = 0.9998) and good assay results in the concentration range of 0.004–0.08 mg/ml (103.3 percent). Further forced degradation investigations using 0.1N Hydrochloric acid (acid degradation), 0.1NNaOH (base degradation), and 3 percent H₂O₂ (Hydrogen peroxide) were carried out using RP-HPLC, and percent degradation values were determined. In peroxide degradation conditions, the medication was shown to be unstable.

Conclusion: In compliance with ICH requirements, the developed procedures were validated.

Downloads

Download data is not yet available.

References

Analytical chemistry [homepage]. Available from: http://www.collinsdictionary.com /dictionary/english/analytical-chemistry.

DRUGBANK. Available from: https://go.online.drug bankDrugbank.com/salts/DBSALT002173 [Last accessed on 15 Jun 2022]

The NHS website available. https://www.medicines/nefopam.

https://www.sigmaaldrich.com/IN/en/product/sigma/sml0909.

Skoog. West and holler. Fundam Princ Anal Chem Eight Ed; 2013. p. 5.

International Conference on Harmonization on Validation of Analytical Procedures: Text and Methodology; 2005.

Pharmaceutical development. Q8 (R2). ICH harmonized tripartite guideline. Current Step 4 version; Aug 2009.

International Conference on Harmonization. Stability guidelines. Vol. Q1. Stability testing guideline for pharmaceutical development; 2019. doi: 10.22214/ ijraset.2019.12163.

USP. Chromatography system suitability. USA Pharmacopeial Convention; 2009.

Snyder LR, Kirkland JJ, Joseph L. Glajch quantitation (Including trace analysis). 2nd ed. Wiley India Pvt, Ltd. 2012. p. 645-9.

Ahuja S, Jespersen N. editors. Compr Anal Chem. 2006. p. 47.

Chauhan A, Mittu B, Chauhan P. Analytical method development and validation: a concise review. J Anal Bioanalytical Tech 2015;6:1.

Schmauser B. Analytical method development. Training workshop. Pharmaceutical development with a focus on Paediatric Formulations. World Health Organization; June 2010.

Validation of analytical procedures: text and methodology. ICH Q2. ICH harmonized tripartite guideline. Registration of Pharmaceuticals for human use. November 2005;R1:4.

General chapters 1225, validation of compendial methods Convention, Inc. United States Pharmacopeia. Rockville, MD: The United States Pharmacopeial; 2007. p. 30.

Sales UV [handbook]. International Marketing Division. 2006 version. Vol. 2. Chapter 1; 2006. p. 1-2.

Beckett AH, Stenlake JB. Practical pharmaceutical chemistry. 4th ed. Part Two: CBS Publishers and Distributors Pvt Ltd; 2007. p. 157-66, 278-300.

Mohsena Am, Hayam M Lotfyb, Amr M Badaweyb, Hesham Salema, Sonia Z Elkhateeb. Application of three novel spectrophotometric methods manipulating ratio Spectra for resolving a pharmaceutical mixture of chlorphenoxamine Hydrochloride and caffeine. International Journal of Pharmacy and Pharmaceutical Sciences. 2013;Suppl 1:5.

J Karpinska. Basic principles and analytical application of derivative spectrophotometry. Joanna Karpinska Institute of Chemistry; 2012. p. 254-70.

Ahuja S, Rasmussen H. HPLC method development for pharmaceuticals. Elsevier Inc; 2007. p. 1-3.

Kromidas S. Practical problem-solving in HPLC. Wiley-VCH Verlag; 2000.

Ahuja S. Chromatography and separation science. Vol. 4. Academic Press; 2003. p. 188-99.

Synder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. 2nd ed. New York: Wiley Interscience; 2007. p. 1-20.

Kazakevich Y, Lubrutto R. HPLC for pharmaceutical scientists. New York: John Wiley & Sons Inc; 2007. p. 107.

http://www.ich.org/file admin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1 A_R2/Step4/Q1A_R2 Guideline.pdf.

Shinde NG, Bangar BN, Deshmukh SM, Sulake SP, Dipak Sherekar. Pharmaceutical forced degradation studies with regulatory consideration. Asian J Res Pharm Sci. 2013;3(4, October-December):178-88.

Nefopam hydrochloride. Available from: http: www.druginfosys.com/drug aspx?

Evans MS, Lysakowski C, Tramer MR. Nefopam for the prevention of postoperative pain: quantitative systematic review. Br J Anaesth. 2008;101(5):610-7. doi: 10.1093/bja/aen267, PMID 18796441.

Singh S, Sharma N, Singla YP. Development and validation of UV spectrophotometric method for quantitative estimation of nefopam hydrochloride in polymethacrylate nanospheres. Int J Pharm Pharm Sci 2016;8(1):414-9.

Aymard G, Warot D, Demolis P, Laville I, Diquet B. Sensitive determination of nefopam and its metabolite desmethyl-nefopam in human biological fluids by HPLC. J Pharm Biomed Anal. 2002 Nov;30(4):1013-21. doi: 10.1016/s0731-7085(02)00443-0, PMID 12408892.

Hong C, ZHANG Li-long HPLC. Determination of nefopam hydrochloride. Acta Acad Med Jiangxi. 2005;3.

Balandin VV, Gorobets ES. Postoperative analgesia with nefopam and non-steroidal anti-inflammatory drugs in patients after surgery for tumors of head and neck. Anesteziol Reanimatol. 2014;1:40-3. PMID 24749308.

Eremenko AA, Sorokina LS, Pavlov MV. The use of central acting analgesic nefopam in postoperative analgesia in cardiac surgery patients. Anesteziol reanimatol. 2013;2:78-82. PMID 24000658.

Chanques G, Sebbane M, Constantin JM, Ramillon N, Jung B, Cisse M. Analgesic efficacy and haemodynamic effects of nefopam in critically ill patients. Br J Anaesth. 2011;106(3):336-43. doi: 10.1093/bja/aeq375, PMID 21205626.

Richards BL, Whittle SL, van der Heijde DM, Buchbinder R. Efficacy and safety of neuromodulators in inflammatory arthritis: a Cochrane systematic review. J Rheumatol Suppl. 2012;90:28-33. doi: 10.3899/jrheum.120339, PMID 22942326.

KaizhiLu HS, Chen Y, Li M, Tian Guopin, Chen J. Ondansetron does not attenuate the analgesic efficacy of nefopam. Int J Med Sci. 2013-01-01.

Taniguchi Y, Ali SZ, Kimberger O, Zmoos S, Lauber R, Markstaller M. The effects of nefopam on the gain and maximum intensity of shivering in healthy volunteers. Anesth Anal. 2010;111(2):409-14. doi: 10.1213/ ANE.0b013e3181e332bb, PMID 20529984.