Abstract

  A rapid, sensitive and simple first order derivative and RP-HPLC methods were developed and validated for simultaneous estimation of diclofenac sodium (DIS) and tramadol hydrochloride (THCL) in bulk and their synthetic mixtures. First derivative UV spectrophotometric method has been developed based on the measurement of the absorbance at two wavelengths i.e. 248.6nm for DIS and 293.2nm for THCL linearity of the calibration curve was obtained in the concentration range of 9-45 µg/ml. for DIS and 6-30 µg/ml. for THCL. In bulk as well as in synthetic mixture, the adequate separation of DIS and THCL was observed through RP-HPLC method. Optimum separation was done using Phenomenexluna ODS C18 (150mm X 4.6 mm i.d., 5μm; particle size) with mobile phase consist of acetonitrile, methanol and phosphate buffer (pH 3) in the ratio of 30:30:40 v/v were used at a flow rate of 1.0 ml/min. Injection volume was 20μl and wavelength set at 274 nm. The retention times were found to be 5.78 min and 1.764 min, for DIS and THCL respectively. Linearity of the developed method was found in the range of 15-90μg/ml and 10-60μg/ml for DIS and THCL respectively. The regression coefficient was 0.999 for both DIS and THCL. These two methods were validated according to the ICH guidelines with suitable level of satisfactory for all the parameters. These two methods were found to be simple, fast, and specific for the determination of DIS and THCL in lab as well as industry purpose.

Keywords: Diclofenac Sodium; Tramadol Hydrochloride; First Order Derivative Method; RP-HPLC; Validation

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Citation

Citation: Suddhasattya Dey., et al. “Simultaneous Estimation of Diclofenac Sodium and Tramadol Hydrochloride Using First Derivative Spectroscopy and RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 5.1 (2021): 83-93.

Copyright

Copyright: © 2021 Suddhasattya Dey., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.