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

[ Vol. 12 , Issue. 1 ]

Author(s):

Byran Gowramma*, Ramachandran Senthil Kumar, Rajagopal Kalirajan, Kaviarasan Lakshmanan and Subramanian Nainar Meyyanathan   Pages 63 - 71 ( 9 )

Abstract:


<P>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. </P><P> 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. </P><P> 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. </P><P> 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.</P>

Keywords:

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

Affiliation:

Department of Pharmaceutical Chemistry, JSS College of Pharmacy, (JSS Academy of Higher Education and Research), Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Analysis, JSS College of Pharmacy, (JSS Academy of Higher Education and Research), Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Chemistry, JSS College of Pharmacy, (JSS Academy of Higher Education and Research), Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Chemistry, JSS College of Pharmacy, (JSS Academy of Higher Education and Research), Udhagamandalam, Nilgiris-643001, Tamilnadu, Department of Pharmaceutical Analysis, JSS College of Pharmacy, (JSS Academy of Higher Education and Research), Udhagamandalam, Nilgiris-643001, Tamilnadu

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