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16/03/14 19:53 Simultaneous Spectrophotometric Estimation Of Dexrabeprazole Andmperidone In Capsule Dosage Form | ganesh pawbake - Academia.

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Simultaneous Spectrophotometric Estimation Of Dexrabeprazole And Domperidone In
Capsule Dosage Form
by ganesh pawbake
more

AvaiIabIconIincat vvv.ijpqa.com
!ntcrnationaI1ournaIoIPlarmaccuticaIQuaIityAssurancc20i0;2(2),Ji-J4
!""#$%&'()%')&*
RcscarclArticIc
SimuItancousSpcctroplotomctricLstimationOIcxrabcprazoIcAnd
ompcridonc!nCapsuIcosagcIorm
SolanS.ClitIangc*,Amir!.MuIIa,GancslR.PavbakcandSagarB.Wanklcdc.
IoJmoslriDr.D.Y.IolillnslilulccjIlormcculicolscicnccsonJRcscorcl
SonlTukoromNogor,Iimpri,Iunc-41101o,Molorosllro,lnJio.
+,"-.+/-
1lrcc I\ spcctroplotomctric mctlods Ior tlc simuItancous dctcrmination oI dcxrabcprazoIc (LXRAB), and
dompcridonc (OM), in capsuIcs vcrc dcvcIopcd in tlc prcscnt vork. Mctlod ! is simuItancous cquation mctlod,
vavcIcngtlscIcctcdarc258.5nm(!"maxIordcxrabcprazoIc)and286.5nm(!" maxIordompcridonc).Mctlod!!invoIvcs
muIticomponcntmodcoIanaIysis,vavcIcngtlscIcctcdarc258.5nm(!"maxIordcxrabcprazoIc)and286.5nm(!"maxIor
dompcridonc). Mctlod !!! is arca undcr curvc mctlod, vavcIcngtl rangc scIcctcd arc 26J.5-25J.5 nm Ior
dcxrabcprazoIc and 2i.5-28i.5 nm Ior dompcridonc rcspcctivcIy. AII tlc mctlods vcrc Iound Iincar bctvccn 5-J5
#g/mI Ior dcxrabcprazoIc and i0-70 #g/mI Ior dompcridonc. 1lc accuracy and prccision oI tlc mctlods vcrc
dctcrmincdandvaIidatcdstasticaIIyvliclslovcdnosigniIicantdiIIcrcnccbctvccntlcrcsuItsobtaincdbytlctlrcc
mctlods.1lcproposcdmctlodsarcliglIyscnsitivc,prcciscandaccuratcandtlcrcIorccanbcuscdIoritsintcndcd
purposc.
012%34.5"$cxrabcprazoIc,dompcridonc,simuItancouscquationmctlod,muIticomponcntmodcoIanaIysis,arca
undcrcurvcmctlod.
!#-.456/-!4#
ClcmicaIIy, cxrabcprazoIc sodium ( LXRAB ) is R
()-isomcroI rabcprazoIc (2-|||4-(J-mctloxypropoxy)-
J-mctlyI-2-pyridinyI|-mctlyI| suIIinyI| iH-
bcnzimidazoIc). !t is a proton pump inlibitor tlat
supprcsscsgastricacidsccrctionbyspcciIicinlibitionoI
tlc gastric H K A1Pasc cnzymc systcm at tlc
sccrctory surIacc oI tlc gastric parictaI ccII.
|i,2|
.
ClcmicaIIy, ompcridonc (OM) is 5-clIoro-i-|i-|J-
(2-oxo-2,J-dilydro-iH-bcnzimidazoI-i-yI)propyI|-
pipcridin-4-yI|-i,J-dilydro-2H-bcnzimidazoI-2-onc. !t
is a dopamincrcccptor ( 2 ) antagonist vlicl is uscd
as anticmctic drug and is oIIiciaI in Britisl
Plarmacopcia .!t incrcascs spontancous gastric activity
and antagonizcs dopaminc inlibition oI gastric
cmptying
|J|
.
ompcridonc aIonc or in combination vitl otlcr drugs
is rcportcd to bc cstimatcd by HPLC
|4-ii|
, LC
| i2 |
,
Spcctroplotomctry
| iJ-i6 |
, HP1LC
| i7 |
, LC-MS
| i8 |

WlcrcasnoanaIyticaImctlodisrcportcdIoranaIysisoI
dcxrabcprazoIc.
Sincc no spcctroplotomctric mctlods arc rcportcd Ior
tlc simuItancous cstimation oI dcxrabcprazoIc &
dompcridonc in combination tlcrcIorc, in tlc prcscnt
vork, a succcssIuI attcmpt las bccn madc to cstimatc
botl tlcsc drugs simuItancousIy by tlrcc simpIc I\-
spcctroplotomctric mctlods (SimuItancous cquation
mctlod, MuIticomponcnt modc oI anaIysis |i|, Arca
undcr curvc mctlod
|20|
.1lc proposcd mctlods vcrc
optimizcd&vaIidatcdaspcr!CHguidcIincs
|2i|
.
7+-1.!+8%+#5%71-945"
!:;<=>?@:<$ A doubIc-bcam Slimadzu I\- \isibIc
spcctroplotomctcr, i700 Plarmaspcc, vitl spcctraI
bandvidtloI2nm,vavcIcngtlaccuracy0.5nmanda
pair oI i-cm matclcd quartz ccIIs vas uscd to mcasurc
absorbanccoIsoIution.
7A<@=BAC$ Standard giIt sampIcs oI dcxrabcprazoIc and
dompcridoncvcrcprovidcdbyLmcurcplarmaccuticaIs
Ltd, Punc. Combincd dosc capsuIc IormuIation
containingdcxrabcprazoIcanddompcridonc(R-Purc,
i0 mg oI dcxrabcprazoIc and J0mg oI dompcridonc,
ManuIacturcd by Lmcurc), vcrc purclascd Irom IocaI
markct.
"DCE@:<% >;@F: MctlanoIic HCL (0.i N ) vas uscd as
soIvcnt.
G=@HA=A<BD:% DI% ;<DJK% ;DC><BD:: AccuratcIy vciglcd
quantity oI dcxrabcprazoIc (5 mg) and dompcridonc (5
mg)vcrctransIcrrcdtotvoscparatc50.0mIvoIumctric
IIask.1lcndiIutcdto tlcmarkvitltlcmctlanoIicHCL
(StocksoIutioni00 #g/mI).
7@<LDF%!$%"B?>C<A:@D>;%@M>A<BD:%?@<LDFN
O/D==@;HD:FB:P%+><LD=$%"DLA:%"N%/LB<CA:P@
AssistantProIcssor,Padmaslrir..Y.PatiI!nstitutcoI
PlarmccuticaIscicnccsandRcscarcl
Sant1ukaramNagar,Pimpri,Punc-4i4i8,Malarasltra,
!ndia.
Ior tlc scIcction oI anaIyticaI vavcIcngtl, soIutions oI
dcxrabcprazoIc (i0g/mI) and dompcridonc (J0 g/mI)
vcrc prcparcd scparatcIy by appropriatc diIution oI
standard stock soIution (i00 #g/mI) vitl mctlanoIic
HCL ( 0.iN ) and scanncd in tlc spcctrum modc Irom
400nmto200nm.cxrabcprazoIclas !" max oI258.5nm
L-MaiI: solanclitIangcrcdiIImaiI.com
Ji

Clillongccl.ol./SimullonccusspcclrcplclcmclriccslimolicncjDcxrohcprozclc.
-AQC@%#D%R%S$%.@;>C<%DI%?A=K@<@F%ID=?>CA<BD:%A:ACT;B;N
7@<LDF% 5=>P% 8AQ@C%/CAB? +?D>:<%DI%F=>P U%DI%CAQ@C%JCAB?
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16/03/14 19:53 Simultaneous Spectrophotometric Estimation Of Dexrabeprazole Andmperidone In Capsule Dosage Form | ganesh pawbake - Academia.edu
Pgina 2 de 4 https://www.academia.edu/6390395/Simultaneous_Spectrophotometr_taken=true&login=wanderquimico@gmail.com&email_was_taken=true
and dompcridonc las !"max oI 286.5 nm. Standard
soIutions vcrc prcparcd laving conccntrations 5-J5
#g/mI Ior dcxrabcprazoIc and i0-70 #g/mI Ior
dompcridonc. 1lc absorbanccs oI tlcsc standard
soIutions vcrc mcasurcd at scIcctcd vavcIcngtl and
caIibration curvcs vcrc pIottcd. 1vo simuItancous
cquations (in tvo variabIcs Ci and C2) vcrc Iormcd
usingabsorptivitycocIIicicntvaIucs.
Ai-(0.0J666)Ci(0.0024)C2 .(i)
A2-(0.0224)Ci(0.0J5i2)C2 .(2)
Wlcrc Ci and C2 arc tlc conccntrations oI
dcxrabcprazoIcanddompcridoncmcasurcdin #g/mI, in
sampIc soIutions. Ai and A2 arc tlc absorbanccs oI
mixturcatscIcctcdvavcIcngtlsi.c.,258.5nmand286.5
nm.
By appIying tlc Cramcr's ruIc to cquation i and 2, tlc
conccntration CLXRAB and COM, can bc obtaincd as
IoIIovs,
A2 (0.0024)Ai(0.0J5i2)
CLXRABV% WWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWW ...(J)
- 0.00i22iJ
Ai(0.0224)A2(0.0J666)
COM - ------------------------------------ % .(4)
-0.00i22iJ
7@<LDF%!!$%7>C<BJD?HD:@:<%?DF@%DI%A:ACT;B;N
Ior tlc cstimation oI drugs in tlc commcrciaI
IormuIations,tvcntycapsuIcsvcrcvciglcdandavcragc
vciglt vas caIcuIatcd. 1lc povdcr cquivaIcnt to 5 mg
dcxrabcprazoIc and i5 mg oI dompcridonc vas
transIcrrcdto50.0mIvoIumctricIIaskcontainingJ0mI
oI mctlanoIic HCL (0.iN) and sonicatcd Ior 20 min.
1lc voIumc vas tlcn madc up to tlc mark vitl
mctlanoIic HCL (0.iN). 1lc rcsuIting soIution vas
appropriatcIydiIutcdtogctapproximatcconccntrationoI
i0 #g/mI oI dcxrabcprazoIc and J0 #g/mI oI
dompcridonc. !n mctlod !, tlc conccntration oI botl
dcxrabcprazoIc and dompcridonc vcrc dctcrmincd by
mcasuringabsorbanccsoIsampIcsoIutionsat258.5nm
(!"
!n tlis mctlod, six mixcd standard soIutions vitl
conccntrationoIdcxrabcprazoIcanddompcridoncintlc
ratio oI i0:J0 #g/mI vcrc prcparcd in mctlanoIic HCL
(0.iN).AIItlcstandardsoIutionsvcrcscanncdovcrtlc
rangc oI 400-200 nm, in tlc muIticomponcnt modc,
using tvo vorking vavcIcngtl 258.5 nm (!"max oI
dcxrabcprazoIc) and 286.5nm (!"max oI dompcridonc).
1lc data Irom tlcsc scans vas uscd to dctcrminc tlc
conccntrationsoItvodrugsincapsuIcsampIcsoIutions.
7@<LDF%!!!$%+=@A%>:F@=%J>=E@%?@<LDFN
Irom tlc ovcrIain spcctra oI botl drugs, arca undcr tlc
curvc in tlc rangc oI 26J.5-25J.5 nm (Ior
dcxrabcprazoIc)and2i.5-28i.5nm(Iordompcridonc)
vcrc scIcctcd Ior tlc anaIysis (Iig.i). 1lc caIibration
curvcsIordcxrabcprazoIcanddompcridoncvcrcpIottcd
in tlc conccntration rangc oI 5-J5 #g/mI and i0-70
#g/mI, rcspcctivcIy. 1lc `X vaIucs Ior botl tlc drugs
vcrc dctcrmincd at tlc scIcctcd AIC rangc. 1lc `X
vaIuc is tlc ratio oI arca undcr tlc curvc at scIcctcd
vavcIcngtlrangcsvitltlcconccntrationoIcomponcnt
in g/Iit. 1lcsc `X vaIucs vcrc tlc mcan oI six
dctcrminations. A sct oI tvo simuItancous cquations
obtaincdbyusingmcan`XvaIucsarcgivcnbcIov.
Ai-(0.J575)Ci(0.0J24)C2(at !"26J.5-25J.5nm)...(5)
A2-(0.226J)Ci(0.J265)C2 (at !"2i.5-28i.5 nm).(6)
WlcrcAiand A2 vcrcarcaundcr curvcoI sampIc at
tlcvavcIcngtlrangc26J.5-25J.5nmand2i.5-28i.5
nm,rcspcctivcIy.0.J575and0.226Jvcrc`X`vaIucsoI
dcxrabcprazoIcatvavcIcngtlrangc26J.5-25J.5nmand
2i.5-28i.5 nm rcspcctivcIy. SimiIarIy 0.0J24and
0.J265 vcrc `X `vaIucs oI dompcridonc at vavcIcngtl
rangc26J.5-25J.5nmand2i.5-28i.5nm,rcspcctivcIy.
1lc conccntration oI dcxrabcprazoIc and dompcridonc
insampIcvasdctcrmincdbyusingtlccquations(5)and
(6).
+;;AT%DI%JAH;>C@%ID=?>CA<BD:%QT%?@<LDF%!X%!!%Y%!!!N
max
oI dcxrabcprazoIc) and 286.5nm (!"
max
oI
dompcridonc) using cquations (J) and (4). Ior mctlod
!!,tlcsamccapsuIcsampIcsoIutionsvcrcsubjcctcdto
anaIysisintlcmuIticomponcntmodcoIinstrumcnt,tlc
conccntration oI botl dcxrabcprazoIc and dompcridonc
dctcrmincd by anaIysis oI spcctraI data oI tlc sampIc
soIution vitl rcIcrcncc to tlc mixcd standards at 258.5
nm (!" max oI dcxrabcprazoIc) and 286.5 nm (!"max oI
dompcridonc).Iormctlod!!!,tlcconccntrationoIbotl
dcxrabcprazoIc and dompcridonc vcrc dctcrmincd by
mcasuringarcaundcrcurvcintlcrangcoI26J.5-25J.5
nm (Ior dcxrabcprazoIc) and 2i.5-28i.5 nm (Ior
dompcridonc) and vaIucs vcrc substitutcd in cquations
(5) and (6) to obtain conccntration oI botl tlc drugs.
RcsuItsoItabIctanaIysisarcslovnin1abIcNo.i
ZACBFA<BD:
1lc proposcd mctlods vcrc vaIidatcd as pcr !CH
guidcIincs.
+JJ>=AJT
7@<LDF% 5=>P% 8AQ@C%/CAB?
[?P\JAH;>C@]
+?D>:<%DI%F=>P
@;<B?A<@F%[?P\
JAH;>C@]
U%DI%CAQ@C%JCAB?
@;<B?A<@F
^%"N5O
LXRAB i0 i0.04 i00.i5 ^ 0.J4 !
OM J0 J0.i2 i00.J60.J5
LXRAB i0 i0.05 i00.5J0.66 !!
OM J0 J0.26 i00.850.77
LXRAB i0 i0.0J i00.270.i8 !!!
OM J0 2.6 .87 0.J8
*McanoI sixcstimation.LXRAB-cxrabcprazoIc,OM-ompcridonc.
lJIQAApril-Junc2010,Vcl2,lssuc2(J1-J4) J2

Clillongccl.ol./SimullonccusspcclrcplclcmclriccslimolicncjDcxrohcprozclc.
-AQC@%_$%.@;>C<%DI%=@JDE@=T%;<>FB@;
7@<LDF%!% 7@<LDF%!!% 7@<LDF%!!!
8@E@C% DI
=@JDE@=T
5=>P
+?<N%DI
F=>P
<AK@:
`P\?C
+?<N%DI
"<FN
5=>P
+FF@F
`P\?C
.@JDE@=T
[U]*%
^%"N5*%
.@JDE@=T
[U]*%
^%"N5*%
.@JDE@=T
[U]*%
^%"N5*%
LXRAB i0 8 i00.50 0.055 i00.78 0.24i .78 0.02
80
OM J0 24 i00.44 0.0J5 i00.JJ 0.J60 i00.0 0.026
LXRAB i0 i0 i00.J5 0.087 i00.J5 0.40 i00.iJ 0.05
i00
OM J0 J0 i00.20 0.2i4 i00.i8 0.iJ7 .88 0.006
LXRAB i0 i2 i00.2J 0.J8i i00.2 0.25 i00.i2 0.02
i20
OM J0 J6 i00.2 0.iJi i00.0i 0.227 i00.J7 0.02
*McanoItlrcccstimation.LXRAB-cxrabcprazoIc,OM-ompcridonc.
16/03/14 19:53 Simultaneous Spectrophotometric Estimation Of Dexrabeprazole Andmperidone In Capsule Dosage Form | ganesh pawbake - Academia.edu
Pgina 3 de 4 https://www.academia.edu/6390395/Simultaneous_Spectrophotometr_taken=true&login=wanderquimico@gmail.com&email_was_taken=true
1o asccrtain tlc accuracy oI tlc proposcd mctlods,
rccovcry studics vcrc carricd out by standard addition
mctlod at tlrcc diIIcrcnt IcvcIs (80, i00 &i20).
1lcrcsuItsoIrccovcrystudicsvcrcsatisIactoryandarc
prcscntcdin1abIcNo.2.
8B:@A=B<T
1lc Iincarity oI mcasurcmcnt vas cvaIuatcd by
anaIyzing diIIcrcnt conccntration oI tlc standard
soIution oI dcxrabcprazoIc and dompcridonc. Ior aII
tlrccmctlods,tlcBccr-Lambcrtsconccntrationrangc
vas Iound to bc 5-J5 #g/mI and i0-70 #g/mI Ior
dcxrabcprazoIcanddompcridoncrcspcctivcIy.
G=@JB;BD:
1lc rcproducibiIity oI tlc proposcd mctlods vcrc
dctcrmincdbypcrIormingcapsuIcassayatdiIIcrcnttimc
intcrvaIsonsamcday(!ntra-dayassayprccision)andon
tlrccdiIIcrcntdays(!ntcr-dayassayprccision).
/4#/86"!4#
AII 1lc tlrcc mctlods vcrc vaIidatcd as pcr !CH
guidcIincs. 1lc standard dcviation and RS
caIcuIatcd Ior tlc proposcd mctlods arc Iov, indicating
ligl dcgrcc oI prccision oI tlc mctlods. 1lc rcsuIts oI
tlcrccovcrystudicspcrIormcdslovtlcligldcgrccoI
accuracyoItlcproposcdmctlods.%
Hcncc, it can bc concIudcd tlat tlc dcvcIopcd
spcctroplotomctric mctlods arc accuratc, prccisc and
scIcctivc and can bc cmpIoycd succcssIuIIy Ior tlc
cstimation oI dcxrabcprazoIc and dompcridonc in
markctcdIormuIation!
.1"68-%+#5%5!"/6""!4#
Ior aII tlc mctlods Iincarity vas obscrvcd in tlc
conccntration rangc oI 5-J5 #g/mI and i0-70#g/mI Ior
dcxrabcprazoIc and dompcridonc, rcspcctivcIy.
CommcrciaIIormuIationscontainingdcxrabcprazoIcand
dompcridonc vcrc anaIyzcd by tlc proposcd mctlods.
Six rcpIicatc anaIysis oI IormuIation vcrc carricd out
and tlc mcan assay vaIucs vcrc Iound in tlc rangc oI
.87 to i00.85 slovn in tabIc no.i .1lc proposcd
mctlods vcrc vaIidatcd as pcr tlc !CH guidcIincs. 1lc
accuracyoItlcproposcdmctlodvasdctcrmincdby
aBPNS$%4E@=CAB:%;H@J<=A%DI%5@b=AQ@H=AcDC@%A:F%5D?H@=BFD:@
lJIQAApril-Junc2010,Vcl2,lssuc2(J1-J4) JJ
16/03/14 19:53 Simultaneous Spectrophotometric Estimation Of Dexrabeprazole Andmperidone In Capsule Dosage Form | ganesh pawbake - Academia.edu
Pgina 4 de 4 https://www.academia.edu/6390395/Simultaneous_Spectrophotometr_taken=true&login=wanderquimico@gmail.com&email_was_taken=true
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