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Acta Biomedica Scientia

Volume 6, Issue 3, 2019
Mcmed International
Acta Biomedica Scientia
Issn
2348 - 215X (Print), 2348 - 2168 (Online)
Frequency
bi-annual
Email
editorabs@mcmed.us
Journal Home page
http://mcmed.us/journal/abs
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Abstract
Title
METHOD DEVELOPMENT AND VALIDATION OF NALTREXONE HCl ANDBUPROPION HCl IN BULK AND PHARMACEUTICAL FORMULATION (CONTRAVE TABLET) BY VISIBLE SPECTROSCOPY (COLORIMETRIC) USING SIMULTANEOUS EQUATION
Author
Sharon J Roy*, Sheeja Velayudhankutty, Y.Haribabu
Email
sharonbph1006@gmail.com
keyword
Naltrexone HCl & Bupropion HCl (pure Drug), CONTRAVE TABLET (8/90mg), Visible Spectroscopy, MBTH reagent, Validation.
Abstract
An accurate, Precise, selective and sensitive economical visible Spectrophotometric- method has been developed and validated for the simultaneous estimation of Naltrexone HCl and Bupropion HClin bulk and tablet(CONTRAVE) dosage form. According to USP standard percentage purity for Naltrexone HCl & Bupropion HCl was found to ≤90-110 and 98-102% respectively. The label claim for Contrave tablet was found to be 8/90mg ie; 8mg of Naltrexone HCl& 90mg of Bupropion HCl(1:11.25 ratio). The method is based on oxidation followed by coupling of 3-methyl-2-benzothiazolinone hydrazine (MBTH) in presence of ferric chloride (catalyst) and Hydrochloric acid to form green colored chromogen. The solvent is used as drug is freely soluble in ethanol and make up with distilled water. The results of analysis have been validated statistically in accordance to ICH guidelines. Linearity was observed in the concentration range of 1-6μg/ml & 11.25- 67.5μg/ml for Naltrexone HCl and Bupropion HCl (Pure Drug) respectively and Recovery studies were carried out to confirm the accuracy of the method. Experimental assay shows that the percentage purity of marketed formulation (Contrave tablet) was found to be 107.81% and 98.54% within the range for Naltrexone HCl and Bupropion HCl respectively and calculated by using Simultaneous Equation Method.
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