A VALIDATED RP-HPLC METHOD FOR SEPARATION AND DETERMINATION OF ETORICOXIB AND PARACETAMOL IN BULK AND PHARMACEUTICAL DOSAGE FORM | ||||
| Bulletin of Pharmaceutical Sciences Assiut University | ||||
| Volume 46, Issue 2, December 2023, Page 969-982 PDF (1.25 MB) | ||||
| Document Type: Original Article | ||||
| DOI: 10.21608/bfsa.2023.327630 | ||||
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| Authors | ||||
Lama Ghazal  1; Mhd Amer Almardini 2; Iyad Allous 1
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| 1Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus university, Syria | ||||
| 2Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Damascus university, Syria President of Al Andalus Private University For Medical Sciences | ||||
| Abstract | ||||
| Etoricoxib is a non-steroidal, anti-inflammatory drug (NSAID) and a selective inhibitor of Cyclooxygenase 2 (COX2), which makes it safer on the gastrointestinal tract than the other NSAIDs. Given the importance of Etoricoxib’s, its combination with paracetamol offers higher efficacy and fewer side effects. In addition to the popularity of this combination in the pharmaceutical industry and the diversity of its manufacturing companies, this study aims to develop a novel, precise, selective, rapid and economic assay method for the simultaneous quantitative determination of Etoricoxib and paracetamol in bulk and pharmaceutical dosage form using reverse phase HPLC. This developed method has a short run time of less than 4 minutes using a C18 column (150×4.6) mm 5μm, a mobile phase of methanol and ammonium acetate (pH =3.5) in a ratio (60:40), respectively. The elution was observed at 245 nm using a PDA detector; the retention times of paracetamol and Etoricoxib were found to be 2.493 and 3.64 min, respectively, and a resolution factor larger than 2. Linearity was established with correlation coefficient values of 0.9991, 0.9994 for both Etoricoxib and paracetamol drugs. Precision was within the relative standard deviation of less than 2% for both drugs, and the percentage recoveries were found to be 99.98% and 99.35% for paracetamol and Etoricoxib, respectively. LOD and LOQ of paracetamol were 1.4 mg/ml and 4.3 mg/ml, respectively, and 0.52 mg/ml and 1.6 mg/ml for Etoricoxib, respectively. The selectivity test results showed no interference from the tablet excipients during the separation process, which verifies that this method is easily applicable to quality control labs and pharmaceutical industries, in addition to being fast, accurate and cost-effective. | ||||
| Keywords | ||||
| Etoricoxib; RP-HPLC; assay; validation; paracetamol; simultaneous | ||||
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