Development and Validation of an Ultra Performance Liquid Chromatography Method for the Determination of Dexketoprofen Trometamol, Salicylic Acid and Diclofenac Sodium.

OBJECTIVES: A simple, fast, accurate and precise method has been developed for the determination of dexketoprofen trometamol (DKP), salicylic acid (SA) and diclofenac sodium (DIC) in the drug solutions using ultra high performance liquid chromatography (UPLC).
MATERIALS AND METHODS: UPLC method is highly reliable and sensitive method to quantify the amount of the active ingredient and the method is validated according to ICH guidelines.
RESULTS: The developed method is found to be precise, accurate, specific and selective. The method was also found to be linear and reproducible. The value of limit of dedection (LOD) of DKP, SA, DIC were found 0.00325 µg/mL, 0.0027 µg/mL and 0.0304 µg/mL, respectively. The limit of quantitation (LOQ) of DKP, SA and DIC were found 0.00985 µg/mL, 0.0081 µg/mL and 0.0920 µg/mL, respectively.
CONCLUSION: Proposed methods can be successfully applicable to the pharmaceutical preparation containing the above mentioned drugs (dexketoprofen trometamol, salicylic acid and diclofenac sodium). Even very small amounts of active substance can be analyzed and validations can be performed easily. ©Copyright 2017 Turk J Pharm Sci, Published by Galenos Publishing House.