Flurbiprofen ve tiyokolşikosidin farmasötik preparatta valide edilmiş bir HPLC yöntemi ile eş zamanlı tayini

Aswaisi H. [2022]. Simultaneous Determination of Flurbiprofen and Thiocolchicoside in Pharmaceutical Preparations by a Validated HPLC method. Yeditepe University, Institute of Health Sciences, Department of Pharmaceutical Chemistry Master Thesis, Istanbul. Simple, rapid, and robust analytical method was presented by using high-performance liquid chromatography (HPLC) for the simultaneous determination of flurbiprofen (FBP) and thiocolchicoside (THC). The stationary phase used for the analysis was an Agilent Poroshell 120 EC-C18 column. An acetate buffer solution (100 mM, pH 4.8) and acetonitrile were used as the mobile phase A and B, respectively The injection volume was 5 µl. The flow rate was adjusted as 0.5 ml/min and column compartment temperature was set up to 40°C. Analytes were monitored at 248 nm by using a diode array detector (DAD). The validation procedure was applied according to the United States Pharmacopoeia. The developed method was found to be linear with a concentration range between 5-100 ppm. The correlation coefficient was calculated as 0.9993 for FBP and 0.9997 for THC. Other validation parameters evaluated were accuracy, precision, linearity, specificity, and robustness-ruggedness. The developed and validated method was successfully applied for HPLC analysis of commercial tablets and gel samples containing FBP and THC without any prior extraction process. The recoveries for FBP and THC were 99.5% and 97.0% in the tablet formulations and 98.6% and 99.3% in the gel formulations, respectively. All the results are acceptable and advanced that the method is appropriate for the proposed use in the assay of binary commercial dosage form and routine quality control. Key words: Flurbiprofen, Thiocolchicoside, HPLC, analysis, validation