Enantiomeric Separation of Meclizine Hydrochloride in Pharmaceutical Dosage Form by HPLC Method

Author(s): Byran Gowramma*, Ramachandran Senthil Kumar, Rajagopal Kalirajan, Kaviarasan Lakshmanan, Subramanian Nainar Meyyanathan

Journal Name: Current Drug Research Reviews
(Formerly Current Drug Abuse Reviews)

Volume 12 , Issue 1 , 2020

Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


Objective: A basic, powerful and isocratic chiral fluid chromatographic technique was created and approved for the enantiomeric partition of meclizine hydrochloride in pharmaceutical dose structure.

Methods: The chromatographic partition was accomplished on Phenomenex® Lux Cellulose 1 (250 mm x 4.6 mm i.d, 5 μm molecule size) section utilizing portable stage framework containing acetonitrile: 25mM ammonium bicarbonate (75:25%v /v). The versatile stage was siphoned on the segment at the stream pace of 1.0 mL/min, and UV recognition was done at 230 nm.

Result: The breaking points of recognition and measurement were observed to be 0.25 μg/mL and 1.00 μg/mL individually, for 20μL infusion volume. The alignment bend demonstrated phenomenal linearity over the focus scope of 1-5 μg/mL for (±) meclizine enantiomers with a relationship coefficient (r2 = 0.999). The recuperation investigation of meclizine from tablet plan was observed to be 97.33% and 98.81% separately. Meclizine standard arrangement and versatile stage were observed to be steady for in any event 32h. The meclizine enantiomers were very much settled with mean maintenance times of about (+) Meclizine at 13.14 min and (-) Meclizine at 14.33 min individually.

Conclusion: The created technique was broadly approved and demonstrated to be hearty, exact, exact and appropriate for the examination of meclizine enantiomers in tablet measurement structure and security investigations of meclizine.

Keywords: Meclizine hydrochloride, enantiomers, chirality, RP-HPLC, ICH, validation.

Willium H. Porter. Resolution of chiral drugs. Pure Appl Chem 1991; 63(8): 1119-22.
Valliappan K. Molecular handedness: Impact on the development of chiral drugs. Indian Drugs 1998; 35(7): 446-57.
Valliappan K, Kannan K, Manavalan R, Muralidharan C. Selection of chromatographic technique (HPLC/HPTLC) for chiral analysis using analytical hierarchy process. Indian J Pharm Sci 2002; 39(5): 277-88.
McConathy J, Owens MJ. Owens. Stereochemistry in drug action. prim care companion. J Clin Psychiatry 2003; 5(2): 70-3.
[http://dx.doi.org/10.4088/PCC.v05n0202] [PMID: 15156233]
Nguyen LA, He H, Pham-Huy C. Chiral drugs: An overview. Int J Biomed Sci 2006; 2(2): 85-100.
[PMID: 23674971]
Bojarski J, Hassan Y. Aboul Enein, Ashraf Ghanem. What’s new in chromatographic enantio separations. Curr Anal Chem 2005; 1: 59-77.
Arai T. Chiral separation of pharmaceuticals possessing a carboxy moiety. J Chromatogr B Biomed Sci Appl 1998; 717(1-2): 295-311.
[http://dx.doi.org/10.1016/S0378-4347(98)00246-1] [PMID: 9832251]
Mehta AC. Direct separation of drug enantiomers by high-performance liquid chromatography with chiral stationary phases. J Chromatogr A 1988; 426(1): 1-13.
[http://dx.doi.org/10.1016/S0021-9673(01)91766-2] [PMID: 3290232]
Valliappan K. Reflections on chiral chromatographic analysis. Indian J Pharm Sci 2005; 67(3): 273-82.
Sethi PD. High performance liquid chromatography. 1 New Delhi 2001; 5(59): 117-51.
Kiyokatsu J. Chromatographic separations based on molecular recognition. New York 1997; pp. 1-66.
Marvin C. McMaster LC/MS A practical user’s guide. New Jersey: John Wiley & Sons 2005; pp. 1-58.
Reynolds DW, Facchine KL, Mullaney JF, Alsante KM, Hatajik TD, Motto MG. Available guidance and best practices for conducting forced degradation studies. Pharm Technol 2002; 26(2): 48-56.
Reynolds DW. Forced degradation of pharmaceuticals. Acta Pharm 2004; 7(3): 56-61.
Thatcher SR, Mansfield RK, Miller RB, Davis CW, Baertschi SW. Pharmaceutical photostability. Pharm Technol 2001; 25(3): 98-110.
Kats M. Forced degradation studies: Regulatory considerations and implementation. Biopharm Int 2005; 18: 7.
Alsante KM, Ando A, Brown R, et al. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv Drug Deliv Rev 2007; 59(1): 29-37.
[http://dx.doi.org/10.1016/j.addr.2006.10.006] [PMID: 17187892]
ICH. Q2A.. Text on validation of analytical procedures international conference on harmonization
ICH. Q3B validation of analytical procedures: J Pharm Biomed Anal
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 2015; 53(5): 793-9.
[http://dx.doi.org/10.1093/chromsci/bmu127] [PMID: 25644814]
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. Pharma Tutor 2017; 5(6): 29-34.
Ashwini D. Pote, Kalyani B. Wagh, Sachin G. Dhandore, Rajendra Khedkar. Development of HPLC method for meclizine hydrochloride by using quality by design approach. World J Pharm Pharm Sci 2018; 7(8): 667-86.
Vinod kumar K, Sudhakar M, Padmanabha Redd Y, Sudheer Reddy M, Lavanya M. RP-HPLC method development and validation for simultaneous estimation of meclizine hydrochloride and nicotinic acid in pharmaceutical dosage form and in plasma Indo american. Pharmacol Res 2014; 4(6): 296-675.
Källén B, Mottet I. Delivery outcome after the use of meclozine in early pregnancy. Eur J Epidemiol 2003; 18(7): 665-9.
[http://dx.doi.org/10.1023/A:1024891618953] [PMID: 12952140]
Oishi R, Shishido S, Yamori M, Saeki K. Comparison of the effects of eleven histamine H1-receptor antagonists on monoamine turnover in the mouse brain. Naunyn Schmiedebergs Arch Pharmacol 1994; 349(2): 140-4.
[http://dx.doi.org/10.1007/BF00169830] [PMID: 7513381]
Shinde P, Rai C, Daswadhar S, Pallavi C, Kasture PV. Development of UV spectrophotometric method of meclizine hydrochloride in bulk and pharmaceutical formulation. Res J Pharm Technol 2012; 5(6): 857-9.
Ravalji MB, Shah SA, Shah DR, Daxina KL, Chauhan RS. Spectroscopic methods for simultaneous estimation of meclizine hydrochloride and caffeine in their combined tablet dosage form. Asian J Res Chem 2011; 4: 1249-53.
Ramakanth Reddy D, Padmanabha Reddy P, Devanna N, Amaranatha Reddy B. A new validated RP-HPLC-DAD method for simultaneous determination of meclizine and caffeine pharmaceutical dosage form. In: J Pharm Sci. 2013.

Rights & PermissionsPrintExport Cite as

Article Details

Year: 2020
Page: [63 - 71]
Pages: 9
DOI: 10.2174/2589977511666191211123337
Price: $65

Article Metrics

PDF: 16
PRC: 1