RP-HPLC QUANTIFIABLE TECHNIQUE DEVELOPMENT FOR EVALUATING PREGABALIN AND ETORICOXIB COMBINATION IN TABLET AND BULK KINDS
Keywords:Etoricoxib, Pregabalin, Fixed dose formulation, RP-HPLC, Stability testing
Objective: This evaluation study aims to initiate a relatively sensitive RP-HPLC quantifiable technique for evaluating pregabalin (PRBN) and etoricoxib (ETRB) combination in tablet and bulk kinds.
Methods: PRBN and ETRB chromatographic evaluations were carried off using the “KNAUER C18 Eurospher II column (250 mm × 4.6 mm × 5 μ)”. The mobile phase (MBP) was driven into the KNAUER C18 Eurospher II column at a 1.0 ml/min run rate with an isocratic elution programme of 65% volume of 0.5 mM sodium perchlorate 35% volume methanol, detected and evaluated the PRBN and ETRB content at 217 nm.
Results: The analysis of PRBN and ETRB is executed inside a run period of 15 min. The RP-HPLC quantifiable technique was developed to separate PRBN and ETRB and likely degradants formed from stress testing by isocratic elution. The RP-HPLC quantifiable technique developed was successfully validated to existing ICH limit guidelines and was confirmed as robust, specific, accurate, selective, precise, sensitive, and linear.
Conclusion: The RP-HPLC quantifiable technique developed here is more valuable and worthy for routine PRBN and ETRB analysis of tablets and bulk kinds.
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