A Method Optimization Study for Atomic Absorption Spectrometric Determination of Nickel Content in Meclizine Hydrochloride

Year 2024, , 1073 - 1080, 30.08.2024

Pridhvi Krishna Gaddey , Raja Sundararajan

https://doi.org/10.18596/jotcsa.1402767

Abstract

Heavy metals are naturally occurring elements. Their widespread distribution in the environment has raised questions about their possible consequences on both human health and the environment. So, the toxicological and safety assessment of these heavy metals is one of the major issues in recent days. An accurate method for the determination of nickel in bulk drugs was required due to its high toxicity risk. The aim of the current study was to develop a validated analytical technique for the determination of nickel content in bulk drugs using an atomic absorption spectrometer. The wavelength was 232 nm, and the integration duration was 5.0 seconds. It was determined that the detection and quantification limits were 0.051 mg/L and 0.15 mg/L, respectively. The recovery rates for nickel concentrations spiked by 50%, 100%, and 150% in meclizine hydrochloride were determined to be 109.33%, 96.5%, and 97.55%, respectively. The status of heavy metals and trace elements in bulk drugs were discussed in this article, along with an easy-to-use AAS approach that can be applied at the industrial level to ensure the quality and uniformity of bulk medications and other related products.

Keywords

Atomic absorption, Catalyst, Flame atomization, Heavy metal toxicity, Nickel

References

• 1. Marguí E, Fontàs C, Buendía A, Hidalgo M, Queralt I. Determination of metal residues in active pharmaceutical ingredients according to European current legislation by using X-ray fluorescence spectrometry. J Anal At Spectrom [Internet]. 2009 Aug 18;24(9):1253–7. Available from: <URL>.
• 2. Piccolo B, O’Connor RT. Atomic absorption spectroscopy. J Am Oil Chem Soc [Internet]. 1968 Nov;45(11):789–92. Available from: <URL>.
• 3. Zhao ZR, Tang W, Yang DC, Fan L. Synthesis of meclizine hydrochloride. Chinese J New Drugs [Internet]. 2008;17(13):1139–44. Available from: <URL>.
• 4. Zambelli B, Ciurli S. Nickel and human health. In: Sigel A, Sigel H, Sigel RKO, editors. Interrelations between Essential Metal Ions and Human Diseases [Internet]. Springer Dordrecht; 2013. p. 321–57. Available from: <URL>.
• 5. Genchi G, Carocci A, Lauria G, Sinicropi MS, Catalano A. Nickel: Human health and environmental toxicology. Int J Environ Res Public Health [Internet]. 2020 Jan 21;17(3):679. Available from: <URL>.
• 6. Ghareeb MM, Mohammedways TM. Development and evaluation of orodispersible tablets of meclizine hydrochloride. Int J Pharm Sci Res [Internet]. 2012;3(12):5101–10. Available from: <URL>.
• 7. Wibble T, Engström J, Verrecchia L, Pansell T. The effects of meclizine on motion sickness revisited. Br J Clin Pharmacol [Internet]. 2020 Aug 3;86(8):1510–8. Available from: <URL>.
• 8. Paudel S, Kumar S, Mallik A. Atomic absorption spectroscopy: a short review. EPRA Int J Res Dev. 2021;6(9):322–7.
• 9. Shinde P, Rai C, Daswadkar S, Chaudhari P, Kasture P V. Development of UV spectrophotometric method of meclizine hydrochloride in bulk and pharmaceutical formulation. Res J Pharm Technol [Internet]. 2012;5(6):857–9. Available from: <URL>.
• 10. Naveen KGS, Srinivas U, Joshi H. Development and validation of spectrophotometric method for simultaneous estimation of meclizine and folic acid in bulk and pharmaceutical dosage forms. PharmaTutor. 2017;5(6):29–34.
• 11. Shinde SA, Sayyed ZM, Chaudhari BP, Chaware VJ, Biyani KR. Development and validation of spectrophotometric method for simultaneous estimation of meclizine hydrochloride and pyridoxine hydrochloride in tablet dosage form. J Pharm Sci Biosci Res [Internet]. 2016;6(1):137–43. Available from: <URL>.
• 12. Bkhaitan MM, Mirza AZ. Spectrophotometric method for determination of meclizine in pure and dosage form via ion pair complex formation using eosin Y. Curr Pharm Anal [Internet]. 2018 Jan 23;14(2):95–100. Available from: <URL>.
• 13. Ibrahim MM, Elzanfaly ES, El-Zeiny MB, Ramadan NK, Kelani KM. Spectrophotometric determination of meclizine hydrochloride and pyridoxine hydrochloride in laboratory prepared mixtures and in their pharmaceutical preparation. Spectrochim Acta Part A Mol Biomol Spectrosc [Internet]. 2017 May 5;178:234–8. Available from: <URL>.
• 14. Ho YH, Wu HL, Wu SM, Chen SH, Kou HS. Quantitative enantiomeric analysis of chlorcyclizine, hydroxyzine, and meclizine by capillary electrophoresis. Anal Bioanal Chem [Internet]. 2003 Jul 1;376(6):859–63. Available from: <URL>.
• 15. Peraman R, Manikala M, Kondreddy VK, Yiragamreddy PR. A Stability-indicating RP-HPLC method for the quantitative analysis of meclizine hydrochloride in tablet dosage form. J Chromatogr Sci [Internet]. 2015 May 1;53(5):793–9. Available from: <URL>.
• 16. Nawaz MS. A new validated stability indicating RP-HPLC method for simultaneous estimation of pyridoxine hydrochloride and meclizine hydrochloride in pharmaceutical solid dosage forms. Chromatogr Res Int [Internet]. 2013 May 7;2013(1):747060. Available from: <URL>.
• 17. Shinde G, Ganesh Shashikant S. Development and validation of RP-HPLC method for simultaneous estimation of meclizine hydrochloride and caffeine in bulk and tablet dosage form. Eur J Pharm Med Res [Internet]. 2019;6(6):433–41. Available from: <URL>.
• 18. Foda NH, Jun HW, McCall JW. Quantitative analysis of meclizine in tablet formulations by HPLC. Anal Lett [Internet]. 1988 Jul;21(7):1177–88. Available from: <URL>.
• 19. Gowramma B, Kumar RS, Lakshmanan K, Kalirajan R, Meyyanathan SN. A new stability-indicating chiral RP-HPLC method for the determination of degradation products in meclizine hydrochloride. Curr Pharm Anal [Internet]. 2021 Sep 30;17(8):1075–87. Available from: <URL>.
• 20. Ubale M, Shioorkar M, Choudhari V. A validated stability-indicating HPLC assay method for meclizine HCl in bulk drug. Int J Adv Pharm Anal [Internet]. 2016;6(3):16–20. Available from: <URL>.
• 21. Naveen Kumar GS, Srinivasa U. Development and validation of HPLC method for simultaneous estimation of meclizine and folic acid in bulk drug and pharmaceutical formulations. Int J Curr Res [Internet]. 2017;9(6):51934–9. Available from: <URL>.
• 22. Reddy MS, Karthik PK, Kumar KV. Simultaneous estimation of meclizine hydrochloride and nicotinic acid in pharmaceutical dosage form by RP-HPLC method. Asian J Pharm Res Heal Care [Internet]. 2013;5(2):73–80. Available from: <URL>.
• 23. Gowramma B, Kumar RS, Kalirajan R, Lakshmanan K, Meyyanathan SN. Enantiomeric separation of meclizine hydrochloride in pharmaceutical dosage form by HPLC method. Curr Drug Res Rev [Internet]. 2020 Jun 19;12(1):63–71. Available from: <URL>.
• 24. Imai T, Kimura S, Imamura Y, Uchiyama K, Iijima T, Underberg WJ, et al. Quantitation of meclizine dihydrochloride in serum by reversed phase ion pair high performance liquid chromatography. J Liq Chromatogr [Internet]. 1987 Sep 1;10(11):2505–12. Available from: <URL>.
• 25. Mary L, Srinivasan R, Mary KL, Kumar DR, Aswini P. Simultaneous estimation of meclizine and nicotinic acid by using RP-HPLC. J Pharm Anal Res [Internet]. 2014;3(4):426–33. Available from: <URL>.
• 26. Wang Z, Qian S, Zhang Q, Chow MSS. Quantification of meclizine in human plasma by high performance liquid chromatography–mass spectrometry. J Chromatogr B [Internet]. 2011 Jan 1;879(1):95–9. Available from: <URL>.
• 27. Byran G, Ramachandran SK, Lakshmanan K, Rajagopal K, Subramania Nainar M. Development and validation of LC/MS method for the determination of meclizine enantiomers in pharmaceutical formulations. Drug Dev Ind Pharm [Internet]. 2021 Mar 4;47(3):361–6. Available from: <URL>.
• 28. Westgate E, Sherma J. Analysis of the active ingredient, meclizine, in motion sickness tablets by high performance thin layer chromatography with densitometric measurement of fluorescence quenching. J Liq Chromatogr Relat Technol [Internet]. 2001 Nov 30;24(18):2873–8. Available from: <URL>.
• 29. Borman P, Elder D. Q2(R1) Validation of analytical procedures. In: Teasdale A, Elder D, Nims RW, editors. ICH Quality Guidelines: An Implementation Guide [Internet]. Wiley; 2017. p. 127–66. Available from: <URL>.