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Acta Biomedica Scientia

Volume 1, Issue 2, 2013
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
NOVEL RPHPLC & UV SPECTROSCOPIC METHOD FOR ESTIMATION OF INVITRO DRUG RELEASE THROUGH DISSOLUTION STUDIES OF DEUTETRABENAZINE
Author
Kalathuru Janeesha, Sandhya K, Dinakar A, Avinash Kumar G
Email
sandhyakota1986@gmail.com
keyword
Deutetrabenazine, UV-Spectrophotometry, RP-HPLC, Pharmaceutical Analysis, Method Validation
Abstract
In this study, UV-Spectrophotometric and RP-HPLC, were developed and validated for the quantitative analysis of Deutetrabenazine in tablet formulations. UV-Spectrophotometry utilized 0.1 N HCL as the solvent, demonstrating simplicity, precision, accuracy, and cost-effectiveness, with a sensitivity range of 10-30 ?g/ml and maximum absorbance at 282 nm. RP-HPLC employed a phenomenex C18 column and an isocratic mobile phase (acetonitrile , 80:20% v/v), offering rapid analysis with a sensitivity range of 10-30 ?g/ml and maximum absorbance at 284 nm. Both methods were validated per USP guidelines, ensuring reliability and suitability. Specificity tests confirmed accurate measurement of Deutetrabenazine amidst sample matrix components. Precision studies showed consistent results (system and method precision), indicating reproducibility. Linearity assessments verified a proportional relationship between analyte concentration and response. Robustness testing demonstrated method reliability under varied conditions. Dissolution studies complemented the methods, providing insights into tablet dissolution profiles with satisfactory performance criteria met. Overall, these validated methods provide robust tools for routine Deutetrabenazine analysis in pharmaceutical formulations, ensuring accurate dosage assessment and quality control in manufacturing. Future validation for other compounds would broaden their applicability in diverse analytical contexts
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