International Journal of Pharmacy and Pharmaceutical Sciences

ISSN- 0975-1491 Vol 2, Issue 4, 2010

ResearchArticle

SIMULTANEOUSSPECTROPHOTOMETRICESTIMATIONOFPARACETAMOLAND LORNOXICAMINTABLETDOSAGEFORM

LAKSHMISIVASUBRAMANIAN*,LAKSHMIK.SANDTINTU.T
DepartmentofPharmaceuticalAnalysis,SRMCollegeofPharmacy,SRMUniversity,Tamilnadu603203Email:lakshmiss@hotmail.com Received:20May2010,RevisedandAccepted:22Jun2010 ABSTRACT Twonewsimple,accurateandeconomicspectrophotometricmethodsinUV/VISregionhavebeendevelopedforthedeterminationofparacetamol andlornoxicaminbulkandtabletformulations.Duetomutual interference,quantitationwascarriedoutbytheproposedmethodsnamely simultaneousequation(Method1)andabsorbanceratio(Method2).ThewavelengthsselectedforMethodAwere257.10nmand288.66nmi.e. the respective max of both the drugs. In Method B two wavelengths 257.10nm, max of paracetamol and 284.36 nm, the isobestic point were selected.Boththemethodswerevalidatedforlinearity,accuracyandprecision. Keywords:Paracetamol,Lornoxicam,UltravioletSpectroscopy,Simultaneousequationmethod,QAnalysis. INTRODUCTION Paracetamol and lornoxicam are available in tablet dosage form. Chemically, Paracetamol (PAR) is N acetylpaminophenol. It has antipyretic and analgesic activity. Lornoxicam (LOR) is (3E)6 chloro3[hydroxy(pyridine2ylamino)methylene]2methyl2,3 dihydro4Hthieno[2,3e][1,2]thiazin4one1,1dioxide. It has non steriodial antiinflammatory activity. Paracetamol is official in I.P1, B.P2andUSP3whilelornoxicamisnotofficialinanyPharmacopoeia, but listed in the Merck Index4. Literature survey reveals many analytical methods for determination of paracetamol such as UV Spectrophotometry5, HPLC611, and Capillary electrophoresis12 methods from pharmaceutical preparations. Few analytical methods for determination of lornoxicam using UV Spectroscopy 13, HPLC14,15 and polarography16 in plasma and pharmaceutical formulation have been reported. However, there are no reported methodsforsimultaneousestimationofbothdrugsincombination. Thispaperpresentstwosimple,rapid,reproducibleandeconomical methodsforthesimultaneousanalysisestimationofboththedrugs frompharmaceuticaldosageform. MATERIALSANDMETHODS Instrument A Perkin Elmer Lambda 25 UVVIS Spectrophotometer, with matchedquartzcellcorrespondingto1cmpathlengthandspectral bandwidth1nm.
[

Materials Standardgiftsamplesofparacetamolandlornoxicamwereprocured from Burgeon Pharmaceuticals, Chennai. Tablets containing both paracetamolandlornoxicamwerepurchasedfromlocalmarket. Stocksolutions The stock solution (100mcg/ml) of paracetamol and lornoxicam were prepared separately by dissolving accurately about 10mg of drug in 10ml 0.1N NaOH and the volume was made up to 100 ml with0.1NNaOH. Preparationofcalibrationcurves Solutions of 10mcg/ml of PAR and LAR were prepared separately. Both the solutions were scanned in the spectrum mode from 200.0nm to 400.0nm. The maximum absorbance of PAR and LAR was observed at 257.10nm and 288.66nm, respectively. PAR and LARshowedlinearityintheconcentrationrangeof210mcg/ml at theirrespectivemaxima.Thecoefficientofcorrelationwasfoundto be0.9991forPARand0.9994forLAR. Method1:Simultaneousequationmethod Paracetamol and lornoxicam were dissolved separately in sodium hydroxide to get 1000 mcg/mL concentration of each drug. These solutions were then diluted suitable in distilled water to get the concentrationof10mcg/mLandthesolutionswerescannedinthe wavelengthrangeof200400nm(Fig1).

Abs

Wavelength
Fig.1:Overlainspectraofparacetamolandlornoxicam From the overlain spectrum of PAR and LOR, two wavelengths namely 257.10 nm and 288.66nm, max of Paracetamol and

Lornoxicamrespectivelywereselected.Thecalibrationcurveswere constructed in the concentration range of 210 g/ml at each

Sivasubramanianetal. IntJPharmPharmSci,Vol2,Issue4,166168 wavelength i.e. 257.10 nm and 288.66 nm. The absorptivity coefficients were determined for both the drugs at the selected wavelengthsandfollowingequationsweremade. A1=0.0656Cx+0.0316Cy..(1) A2=0.0295Cx+0.0344Cy.(2), whereA1andA2areabsorbanceofsampleat257.10nmand288.66 nm,respectively. 0.0656 and 0.0295 are absorptivities of paracetamol at 257.10 nm and288.66nmrespectively. 0.0316 and 0.0344 are absorptivities of lornoxicam at 257.10 nm and288.66nmrespectively. Cx and Cy are concentrations of paracetamol and lornoxicam respectively. Method2:AbsorptionRatio/QAnalysisMethod Fromtheoverlainspectrumofparacetamolandlornoxicam(Fig1), two wavelengths were selected, one at 257.10 nm the max of Paracetamol and other at 284.36 nm, an isoabsorptive point for boththedrugs.Thesolutionswerepreparedinthesimilarmanner asmentionedinthepreviousmethod.Theabsorbancevalueswere measured at selected wavelengths. The concentration of each component was calculated by mathematical treatment of the followingmentionedequations. ForParacetamol, Q0Q2A CX= a1 ForLornoxicam, Q0Q1 CY= Q2Q1 a2 A

Where,CxandCyareconcentrationsofPARandLORrespectively. A1 is the absorbance of sample at isoabsorptive wavelength 284.36nm. a1 and a2 are absorptivity of PAR and LOR at isoabsorptive wavelength284.36nm. Q1=AbsorbanceofPARat257.10nm/AbsorbanceofPARat284.36 nm Q2=AbsorbanceofLORat257.10nm/AbsorbanceofLORat284.36 nm Q0 = Absorbance of sample solution at 257.10 nm/ Absorbance of samplesolutionat284.36nm Analysisoftabletformulation Twenty tablets were weighed and crushed to fine power. The amountofpowderequivalentto500mgofPARand8mgofLORwas weighed and transferred to 100ml volumetric flask. The drug contentwasshakenwith 25mlof0.1NNaOHandwaskeptinultra sonicator for 20min.Finally,the volumewasmadeuptothemark with distilled water. The solution was filtered through Whatman filter No.41. The filtrate was further diluted to obtain sample solutions of concentrations within BeerLamberts range. The absorbance of sample solutions were measured at selected wavelengths for the estimation of PAR and LOR. The values were replacedintheabovementionedequationsandtheconcentrationof each drug was calculated by both the methods. Recovery studies werecarried out at 80%, 100%and 120%level of label claim.The proposed methods were validated statistically and the results are representedinTable1.

Q1Q2

Table1:Assayoftablets Method I II Tablet T1 T2 T1 T2 Labelclaim(mg/tablet) PAR LOR 500 8 500 8 500 8 500 8 %Labelclaimfound PAR LOR 98.9 101.1 102.4 103 99 101 100 103 Standarddeviation PAR LOR 0.05 0.04 0.03 0.02 0.02 0.03 0.04 0.05 %Recovery PAR 98.7 100.8 98.9 97.8 LOR 102 101 101.9 102.1

T1LorsumoForte,AlkemLaboratoriesLtd,Mumbai,T2LRn8P,GlenmarkPharmaceuticalLtd,HimachalPradesh

RESULTSANDDISCUSSION Theproposedmethodsaresimple,accurate,costeffectiveandrapid. The statistical analysis of the methods proves that they are reproducibleandefficientforthesimultaneousanalysisofboththe drugsinpharmaceuticaldosageformwithoutanypriorseparation. These methods are convenient and free from interferences of excipients and hence can be employed for routine quality control analysis. ACKNOWLEDGEMENT The authors thank M/S Burgeon Pharmaceuticals Ltd, Chennai, for providingthegiftsamplesofparacetamolandlornoxicam. REFERENCES 1. 2. 3. 4. 5. TheIndianPharmacopoeia,1996edition,Vol.II,554 TheBritishPharmacopoeia,2007edition,Vol.II,1575. USPNFAsianedition2007volume2,1269. Merck Index an encyclopedia of chemicals and drugs and biologicals,13thedition,5612. Wadher SJ, Pathankar PR, Manisha Puranik, Ganjiwale RO, Yeole PG: Simultaneous spectrophotometric estimation of Paracetamol

and Metoclopromide HCl in solid dosage form. Indian J of Pharm Sci2008;70(3):393395. 6. Ghada M, Hadad, Samy Emara, Waleed, Mahmand MM: Stability indicatingRPHPLCmethodfordeterminationofParacetamolwith dantrolene and Cetrizine and Pseudoephedrine in two pharmaceuticaldosageforms.Talanta2009;79:13601367. 7. Udupa N, Karthik A, Subramanian G, Ranjith Kumar A: Simultaneous estimation of Paracetamol and Domperidone by HPLCmethod.IndianJPharmSci2007;69(1):140144. 8. SubramanianG,VasudevanM,RavishankarS,SureshB:Validation of RPHPLC method for simultaneous determination of Paracetamol, Methocarbamol, Diclofenac potassium in tablets. IndianJPharmSci2005;67(2):260263. 9. Fijalek Z, WyszeckaKaszuba E, WarownaGrzeskiewicz M: HPLC with amperometric detection for the determination of 4 aminophenol, the main impurity of Paracetamol in multicomponent analgesic preparation. J Pharm Boimed Anal 2003;32:10811086. 10. LotfiMonser,FridaDarghouth:SimultaneousLCdeterminationof Paracetamolandrelatedcompoundinpharmaceuticalformulation using carbon based column. J of Pharm Biomed Anal. 2002; 27: 851860.

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Sivasubramanianetal. IntJPharmPharmSci,Vol2,Issue4,166168 11. VasudevanM,RavisankarS,RavibabuT,Nagarajan:Estimationof acetaminophen, dextropropoxyphene and oxyphenbutazone in combineddosageformbyHPLCmethod.IndianJPharmSci2000; 62(2):122125. Shulin Zahao, Dan Xiao, Wenling Bai, Hongyan Yuan: Capillary electrophoresiswithchemiluminescencedetectionofParacetamol. AnalChimActa2006;559:195199. NemutluE,DemircalS,KirS:Zeroorderandfirstorderderivative UV Spectrophotometric method for determination of Lornoxicam in pharmaceutical preparation. De Pharmazie 2005; 60 (6): 421 425. 14. YoungHoonKin,HyeYoungJi,EunSeokPark,SooWanChae,Hye Sik Lee: LCTandem Mass Spectrometric determination of Lornoxicam in human plasma,. Archieves of Pharmacal Research 2007;30(7):905910. 15. KiranR.Patil,S.DevanandB.Shinde,VipulP.Rane,JaiprakashN, Sangshetti: Stability indicating LC method for analysis of Lornoxicam in dosage form. Chromatographia 2009; 69: 1001 1005. 16. Sule Aycan, Nisa Kocak, Ibrahim Cetin: Polarographic determinationofLornoxicaminpharmaceuticalformulation.C.B.U JournalofScience2009;1118.

12. 13.

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