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TITLE:

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TRAMADOL HYDROCHLORIDE AND DICLOFENAC IN BULK DRUGS AND PHARMACEUTICAL DOSAGE FORMS

AUTHORS:

Shaik. Reshma, Shaik. Althaf, M. Siva prasad

ABSTRACT:

The aim of the present work was to develop and validate a simple, efficient, economical method for the analysis of Tramadol and Diclofenac in pharmaceutical dosage forms by Rp-HPLC.A hypersil C18 reverse phase column ( 4.6 × 200,5μm ) with mobile phase containing 10mm phosphate buffer (pH-4.5): Acetonitrile(30:70v/v) is used and eluents monitored at 270nm.The Retention time of Tramadol and Diclofenac was 2.34 and 4.57 respectively. The validated characteristics, included, specificity, Linearity, LOD, LOQ, Precision, Accuracy, Robustness, Validation acceptance criteria were met in all cases. The percent recoveries ranged between 95% and 105%. The RSD was found to be less than 2. The method could be successfully used for the analysis of Tramadol and Diclofenac in bulk and Pharmaceutical dosage forms. Key Words: Rp-HPLC, Method development, Tramadol, Diclofenac, Validation.

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