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Abstract

This review article represents the collection and discussion of various analytical methods available in the literature for the simultaneous estimation of Naloxone and Buprenorphine in pharmaceutical and biological samples consisting of HPLC, UV-visible method, near-IR spectroscopy, spectrofluorometry, and hyphenated techniques such as LC-MS, LC-MS/MS, UPLC-MS/MS, and GC-MS. The anticipated review provides details about the comparative utilization of various analytical techniques for the determination of Naloxone and Buprenorphine. When it comes to offering solutions like development, analytical techniques are crucial. An overview and classification of the many analytical techniques used to identify supply issues will be provided in this article. In the quality assurance and internal control of the majority of pharmaceutical medications and preparations, pharmaceutical analysis plays a special function. The need for innovative analytical methods in the pharmaceutical business has increased as a result of the fast development of the pharmaceutical and pharmaceutical industries in many regions of the world. So, developing one's analytical abilities has become a beneficial learning process. Analytical equipment improvements have led to recent breakthroughs in analytical procedures.

Keywords

Naloxone, Buprenorphine, Analytical methods, Pharmacology, Pharmacokinetics, HPLC Method

Reference

  1. K. Kalyani, V. Anuradha, A Simple Stability Indicating Method Development and Validation for the Simultaneous Estimation of Naloxone Hydrochloride and Buprenorphine Hydrochloride in Pharmaceutical Dosage Forms by RP-HPLC, Ijppr.Human, 2016; Vol. 6 (3): 206-222.
  2. Dhanashree a. Mundhey, nidhi p. Sapkal, Simultaneous Quantification Of Buprenorphine Hcl And Naloxone Hcl By Vierordt’s Method, Int J Pharm Pharm Sci, Vol 8, Issue 1, 101-107.
  3. Effat Souria, Farzaneh Sadat Ahmadi, Validated Spectrophtometric Method for Simultaneous Determination of Buprenorphine and Naloxone in Pharmaceutical Dosage Forms, Iranian Journal of Pharmaceutical Research (2017),16 (1): 112-119.
  4. Dr. Gampa Vijay Kumar, G. Sravanya, Analytical Method Development and Validation for the Simultaneous Estimation of Buprenorphine and Naloxone by RP- HPLC Method, JPBMAL, 2019, 7(1): 01-06.
  5. Krishnasarma, Copyrights & Pathy, Krishna Sarma. (2018). Scho J Food & Nutr Route Evaluation and Analytical HPLC Method Development of Buprenorphine, Naloxone, and Comparison Overall Efficiency of Naltrexone Nalbuphine Traces the Evolution of Various Approaches.
  6. Vidhi N. Patel, Mitali H. Jasani, Stability indicating analytical method development and validation for estimation of buprenorphine hcl and naloxone hcl dihydrate, WJPPS, Vol 5, Issue 6, 2016. 
  7. Katasani Damodar, Analytical Method Development and Validation for the Simultaneous Estimation of Buprenorphine Hydrochloride and Naloxone Hydrochloride in Pharmaceutical Dosage Forms By RP-HPLC.” International Journal of Pharmaceutical & Biological Archive 2 (2011)
  8. Irina Dioumaeva, LC/MS/MS of Buprenorphine and Norbuprenorphine in Whole Blood Using Agilent Bond Elut Plexa PCX and an Agilent Poroshell 120 Column, Agilent Technologies, Inc., 2014, 2017 Printed in the USA January 27, 2017. 
  9. Tikhomirov, M.; Po ´zniak, B.; Sniegocki, T. High-Performance ´ Liquid Chromatography-Tandem Mass Spectrometry for Buprenorphine Evaluation in Plasma—Application to Pharmacokinetic Studies in Rabbits. Molecules 2021, 26, 437
  10. Available from: https://go.drugbank.com/salts/DBSALT000126
  11. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Naloxone-hydrochloride
  12. Available from: https://go.drugbank.com/salts/DBSALT000019
  13. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Buprenorphine-hydrochloride
  14. Sarah J. Phillips, Alison Oliveto, Development and Validation of a Rapid LC-MS/MS based Method to Quantitate Gabapentin and Buprenorphine in Human Serum, Rapid Commun Mass Spectrom. 2021 July 31; 35(14): e9104. doi:10.1002/rcm.9104.
  15. Dhanashree Arun Mundhey, Vishal V. Rajkondawar, A Study of Method Development, Validation and Forced Degradation for Quantification of Buprenorphine Hydrochloride in a Microemulsion Formulation, Journal of Applied Pharmaceutical Science Vol. 6 (10), pp. 159-169, October, 2016. 
  16. Naser F Altannak, Liquid Chromatography-Mass Spectrometry Method To Assess Naloxone Hydrochloride Photostability Under Artificial Light And Sunlight Exposure At Room Temperature, Asian J Pharm Clin Res, Vol 8, Issue 5, 2015, 309-311.
  17. Limon Khatun Nahar, Rebecca Andrews and Sue Paterson, Validated Method for the Quantification of Buprenorphine in Postmortem Blood Using Solid-Phase Extraction and Two-Dimensional Gas Chromatography –Mass Spectrometry, Journal of Analytical Toxicology 2015;39:519 –525. 
  18. Xiaoyue Shan, Chengjian Cao, Analytical Approaches for the Determination of Buprenorphine, Methadone and Their Metabolites in Biological Matrices, Molecules 2022, 27, 5211. 
  19. Ankit Rochani, PhD; Vinh Nguyen, Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome, J Pediatr Pharmacol Ther 2021;26(4):395–404.

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Kalpana C. Sable
Corresponding author

Department of Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik

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Vinayak M. Gaware
Co-author

Department of Pharmaceutical Chemistry, PRES College of Pharmacy (Women’s), Chincholi, Nashik

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Mayur T. Gaikar
Co-author

Department of Pharmaceutical Chemistry, PRES College of Pharmacy (Women’s), Chincholi, Nashik

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Vivekanand A. Kashid
Co-author

Dr. Kolpe Institute of Pharmacy, Kolpewadi, Kopargaon, Ahmednagar

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Jaya V. Mehetre
Co-author

Department of Quality Assurance, PRES College of Pharmacy (Women’s), Chincholi, Nashik

Kalpana C. Sable*, Vinayak M. Gaware, Mayur T. Gaikar, Vivekanand A. Kashid, Jaya V. Mehetre, Trupti P.Bhalekar, A Review On Analytical Methods For Estimation Of Naloxone Hcl And Buprenorphine Hcl In Pharmaceutical Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 6, 27-38. https://doi.org/10.5281/zenodo.8028071

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