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Development and Validation of a Hptlc Method for the Simultaneous Estimation of Rofecoxib and Tizanidine Hydrochloride in Tablet Dosage Form

Author(s): A. Lakshmana Rao and D. Praveen Varma

A simple, precise, accurate and rapid high performance thin layer chromatographic method has been developed and validated for the estimation of rofecoxib and tizanidine hydrochloride simultaneously in combined pharmaceutical dosage forms. The stationary phase used was pre-coated silica gel 60F254.The mobile phase used was a mixture of methanol : acetone in the ratio of 1 : 1v/v. The detection of spots was carried out at 254 nm. The method was validated in terms of linearity, accuracy, precision, specificity and reproducibility. The calibration curve was found to be linear between 2.204 to 3.016 μg/spot for rofecoxib and 0.180 to 0.260 μg/spot for tizanidine hydrochloride. The limit of detection and limit of quantification for rofecoxib were found to be 0.70 and 2.20 μg/spot, respectively and for tizanidine hydrochloride 0.052 and 0.16 μg/spot, respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.

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