Development and Validation of RP-HPLC Method for Simultaneous Determination of Diclofenac Sodium and Tizanidine Hydrochloride in Bulk and Tablet Formulation
Keywords:
Diclofenac Sodium, Tizanidine Hydrochloride, High Performance Liquid Chromatography.Abstract
A reverse phase high performance liquid chromatographic method (RP-HPLC) hasbeen developed for the simultaneous estimation of Diclofenac sodium (DICS), and Tizanidine Hydrochloride (TIZH) in the pharmaceutical formulation. The chromatographic column used was a reverse phase 4.6ï‚´250 mm Hypersil C18 HPLC column with 5ïm (particles) packing. The mobile phase was ACN: Phosphate buffer pH 7.0 (50:50 v/v) delivered at a flow rate of 1.0 mL/min. The injection volume was 25 ïL. Elute was analyzed by a UV detector set at 220 nm .Linearity was obtained inthe concentration range of 2-10 μg/ml for DICS, 2.5- 12.5 μg/ml Tizanidine hydrochloride. The method was statistically validated and RSD was found to be less than 2% indicating high degree of accuracy and precision of the proposed HPLC method. Due to its simplicity, rapidness, high precision and accuracy, the proposed RP-HPLC method may be used for determining Diclofenac Sodium and Tizanidine Hydrochloride in bulk drug samples.
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