SIMULTANEOUS QUANTIFICATION OF PENTAZOCINE AND NALOXONE BY STABILITY INDICATING REVERSE-PHASE-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD
PENTAZOCINE AND NALOXONE HPLC ANALYSIS
Objective: The objective of the study was to develope a stability indicating high-performance liquid chromatographic (HPLC) method for simultaneous assay of pentazocine and naloxone in bulk and tablets.
Methods: Pentazocine and naloxone were analyzed on Dionex C18 column using 0.1M K2HPO4 buffer (pH 4.0) and methanol (60:40, v/v) as the mobile phase. The concentration of pentazocine and naloxone was quantified by photodiode array detector set at 248 nm. The method was validated in compliance with ICH rules. Pentazocine and naloxone tablet formulation was subjected to forced degradation such as acid, neutral and alkali hydrolysis, oxidation, photo, and thermal degradation.
Results: The method was linear, with R2=0.9999 in the concentration range 100–300 μg/ml for pentazocine and R2=0.9995 in the concentration range 1–3 μg/ml for naloxone. The level of detection and quantification was 0.097 μg/ml and 0.322 μg/ml for pentazocine and 0.0073 μg/ml and 0.0243 μg/ml for naloxone, respectively. The degraded products are resolved well from pentazocine and naloxone with significantly different retention time values. From validation results, it was proved that the method is selective, precise, robust, and accurate for the estimation of pentazocine and naloxone simultaneously.
Conclusion: The developed stability-indicating HPLC method can be applied for quantitative determination of pentazocine and naloxone in tablets.
2. Craft RM, McNiel DM. Agonist/antagonist properties of nalbuphine, butorphanol and (-)-pentazocine in male vs. Female rats. Pharmacol Biochem Behav 2003;75:235-45.
3. Hoskin PJ, Hanks GW. Opioid agonist-antagonist drugs in acute and chronic pain states. Drugs 1991;41:326-44.
4. Wang N, Wang L, Gao Y, Zhou H, Wang J. Analgesic effect of preoperative pentazocine for laparoscopic cholecystectomy. Cureus 2016;8:e948.
5. Xu HQ, Xing JM, Jia R. Clinical observation of pentazocine for postoperative intravenous analgesia in patients with lumbar herniation. Zhongguo Gu Shang 2010;23:838-40.
6. Dhanalakshmi K. Opioid Analgesics. In: Pain Management. Vol. 2., Ch. 113. Netherlands: Elsevier Publications; 2007. p. 939-64.
7. Chimbar L, Moleta Y. Naloxone effectiveness: A systematic review. J Addict Nurs 2018;29:167-71.
8. van Dorp E, Yassen A, Dahan A. Naloxone treatment in opioid addiction: The risks and benefits. Expert Opin Drug Saf 2007;6:125-32.
9. Lynn RR, Galinkin JL. Naloxone dosage for opioid reversal: Current evidence and clinical implications. Ther Adv Drug Saf 2018;9:63-88.
10. Connors NJ, Nelson LS. The evolution of recommended naloxone dosing for opioid overdose by medical specialty. J Med Toxicol 2016;12:276-81.
11. Elzey MJ, Fudin J, Edwards ES. Take-home naloxone treatment for opioid emergencies: A comparison of routes of administration and associated delivery systems. Expert Opin Drug Deliv 2017;14:1045-58.
12. FDA Approved Drug Products. Available from: https://www. accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview. process&ApplNo=074736. [Last accessed on 2019 Jun].
13. Pentazocine and Naloxone (Oral Route). Drugs and Supplements, Mayoclinic. Available from: https://www.mayoclinic.org/drugs-supplements/pentazocine-and-naloxone-oral-route/description/drg- 20074147. [Last accessed on 2019 Jun].
14. Pentazocine and Naloxone Pentazocine Hydrochloride and Naloxone Hydrochloride Tablet. Dailymed. Available from: https://dailymed. nlm.nih.gov/dailymed/drugInfo.cfm?setid=a28450a0-ac93-4235-b9a6- 58cdf24773cb. [Last accessed on 2019 Jun].
15. Sastry CS, Rekha TV, Satyanarayana A. Spectrophotometric determination of pentazocine in pharmaceutical formulations. Indian J Pharma Sci 1998;60:55-8.
16. Revanasiddappa HD, Veena MA. A sensitive spectrophotometric determination of ritodrine, pentazocine, isoxsuprine hydrochlorides and amoxicillin in pure and pharmaceutical samples. E-J Chem 2008;5:100-6.
17. Poprzen V, Radulovi? D. UV-densitometry determination of pentazocine hydrochloride in tablets after low temperature extraction. Vojnosanit Pregl 2001;58:267-71.
18. Kelly JW, Stewart JT, Blanton CD. HPLC separation of pentazocine enantiomers in serum using an ovomucoid chiral stationary phase. Biomed Chromatogr 1994;8:255-7.
19. Hiedaki M, Kengo O, Ken-Ich H, Makoto S, Kazuhiro I, Hideo N, et al. Quantification of pentazocine in human plasma by HPLC with electrochemical detection. J Liquid Chromatogr 1992;15:3247-60.
20. Moeller N, Dietzel K, Nuernberg B, Geisslinger G, Brune K. High-performance liquid chromatographic determination of pentazocine in plasma. J Chromatogr 1990;530:200-5.
21. Ali RA, Ali AE, Saraji M. Rapid determination of pentazocine in human plasma and urine by a potentiometric method. Anal Lett2009;42:571-83.
22. Seno H, Kumazawa T, Ishii A, Matsushima H, Watanabe-Suzuki K, Suzuki O, et al. Determination of pentazocine in human whole blood and urine by gas chromatography/surface ionization organic mass spectrometry. J Mass Spectrom 2000;35:33-8.
23. Gil-Alegre ME, Barone ML, Torres-Suárez AI. Extraction and determination by liquid chromatography and spectrophotometry of naloxone in microparticles for drug-addiction treatment. J Sep Sci 2005;28:2086-93.
24. Mostafa ST, Mohamed EM, Mahmoud MA. Determination of naloxone hydrochloride in dosage form by high-performance liquid chromatography. J Liquid Chromatogr 1983;6:1491-97.
25. Panchagnula R, Sharma P, Khandavilli S, Varma MV. RP-HPLC method and its validation for the determination of naloxone from a novel transdermal formulation. Farmaco 2004;59:839-42.
26. Reid RW, Deakin A, Leehey DJ. Measurement of naloxone in plasma using high-performance liquid chromatography with electrochemical detection. J Chromatogr 1993;614:117-22.
27. Franklin M, Odontiadis J. Determination of naloxone in human plasma by high-performance liquid chromatography with coulometric detection. J Chromatogr B Biomed Appl 1996;679:199-203.
28. Fang WB, Chang Y, McCance-Katz EF, Moody DE. Determination of naloxone and nornaloxone (noroxymorphone) by high-performance liquid chromatography-electrospray ionization- tandem mass spectrometry. J Anal Toxicol 2009;33:409-17.
29. International Conference on Harmonization, Stability Testing of New Drug Substances and Products (Q1AR2). Geneva, Switzerland: Proceedings of the International Conference on Harmonization; 2003.
30. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2 (R1). Geneva, Switzerland: ICH; 2005.
31. Sharma S, Goyal S, Chauhan K. A review on analytical method development and validation. Int J Appl Pharm 2018;10:8-15.
32. Hemant KJ, Umakant SJ. Development and validation of RP-HPLC method for estimation of darunavir ethanolate in bulk and tablets. Int J Pharm Pharm Sci 2015;7:386-9.
33. Babu GR, Rao AL, Rao JV. A rapid RP-HPLC method development and validation for the quantitative estimation ribavirin in tablets. Int J Pharm Pharm Sci 2015;7:60-3.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.