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HPTLC Method for determination of Terbinafine in the Bulk drug and ...

HPTLC Method for determination of Terbinafine in the Bulk drug and ...

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Suma.B.V.et al /Int.J. ChemTech Res.2011,3(2) 747<br />

Fig 5 Representative chromatogram <strong>of</strong> <strong>Terb<strong>in</strong>af<strong>in</strong>e</strong> degraded under UV radiation<br />

Discussion<br />

The validated <strong>HPTLC</strong> method employed here proved<br />

to be simple, specific, accurate, precise, sensitive,<br />

robust <strong>and</strong> stability <strong>in</strong>dicat<strong>in</strong>g. The developed method<br />

is able to discrim<strong>in</strong>ate between <strong>Terb<strong>in</strong>af<strong>in</strong>e</strong><br />

hydrochloride <strong>and</strong> its possible degradation products.<br />

Statistical analysis proves that <strong>the</strong> method is suitable<br />

<strong>for</strong> <strong>the</strong> analysis <strong>of</strong> <strong>Terb<strong>in</strong>af<strong>in</strong>e</strong> hydrochloride as bulk<br />

<strong>drug</strong> <strong>and</strong> <strong>in</strong> pharmaceutical <strong>for</strong>mulation with out any<br />

References<br />

1. British Pharmacopeia 2007,Vol II, 200-2001<br />

2. Petrany G., Ryder N. S., Stütz A., Allylam<strong>in</strong>e<br />

derivatives: new class <strong>of</strong> syn<strong>the</strong>tic antifungal<br />

agents <strong>in</strong>hibit<strong>in</strong>g fungal squalene epoxidase,<br />

Science, 1984, 224, 1239-1241<br />

3. Krishna R Gupta,sonali.S.Askarkar <strong>and</strong> Sudhir<br />

G.Wadodkar. Stanbility <strong>in</strong>dicat<strong>in</strong>g RP-HPLC<br />

method <strong>for</strong> simultaneous <strong>determ<strong>in</strong>ation</strong> <strong>of</strong><br />

astrovasta<strong>in</strong> <strong>and</strong> nicot<strong>in</strong>ic acid from <strong>the</strong>ir<br />

comb<strong>in</strong>ed dosage <strong>for</strong>m. Eutrasian<br />

.J.Anal.chem,2009,4(3) 294-303.<br />

4. ICH Q1A Stability test<strong>in</strong>g <strong>of</strong> new <strong>drug</strong> substances<br />

<strong>and</strong> products <strong>in</strong> proceed<strong>in</strong>g <strong>of</strong> <strong>the</strong> <strong>in</strong>ternational<br />

<strong>in</strong>terference from <strong>the</strong> excipients. Hence, this proposed<br />

method can be used <strong>for</strong> <strong>the</strong> rout<strong>in</strong>e analysis <strong>of</strong><br />

<strong>Terb<strong>in</strong>af<strong>in</strong>e</strong> hydrochloride <strong>in</strong> pure, tablet <strong>for</strong>m <strong>and</strong> <strong>in</strong><br />

its degraded products.<br />

Acknowledgement<br />

The authors are thankful to Gokula Education<br />

Foundation <strong>for</strong> provid<strong>in</strong>g necessary facilities to carry<br />

out <strong>the</strong> research work.<br />

conference on harmonization, geneva, october<br />

1993.<br />

5. Majumdar T. K., Bakthiar R., Tse F. L.,<br />

Determ<strong>in</strong>ation <strong>of</strong> terb<strong>in</strong>af<strong>in</strong>e (Lamisil) <strong>in</strong> human<br />

hair by microbore liquid chromatography /<br />

t<strong>and</strong>em mass spectrometry, Rapid<br />

communications <strong>in</strong> mass spectrometry, 2000,<br />

14(14), 1214 – 1219<br />

6. Brignol N., Bakhtiar R., Dou L., Majumdar T.,<br />

Tse F. L., Quantitative analysis <strong>of</strong> terb<strong>in</strong>af<strong>in</strong>e<br />

(Lamisil) <strong>in</strong> human <strong>and</strong> m<strong>in</strong>ipig plasma by liquid<br />

chromatography t<strong>and</strong>em mass spectrometry,<br />

Rapid communications <strong>in</strong> mass spectrometry,<br />

2000, 14(3), 141-149

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