NOVEL HPLC-UV METHOD USING VOLATILE BUFFER FOR SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Keywords:
Amlodipine, Atorvastatin, Simultaneous, Dissolution, HPLC, Quantification, Volatile bufferAbstract
Objective: The purpose of this work was to develop and validate a novel HPLC-UV method using triethylamine (TEA) as a volatile buffer for simultaneous determination of amlodipine besylate (AML) and atorvastatin calcium (ATV).
Methods: System suitability, linearity, limit of detection (LOD), limit of quantification (LOQ), selectivity, accuracy, and precision was validated using Hitachi L-2000 system with detector: DAD L-2455 at a detected wavelength of 245 nm. Stationary phase: Phenomenex Luna RP-C18 (250 mm x 4.6 mm, 5 µm) and mobile phase: acetonitrile-methanol-TEA pH 4.0 (ratio 52:18:30 v/v/v) were used. Samples' volume of 20 µl was run at room temperature with the flow rate at 1 ml/min.
Results: The linearity demonstrated good correlation in the concentration range at 2-40 ppm and 4-80 ppm for AML and ATV, respectively. The method was repeatable with relative standard deviation (RSD) of the intermediate precision test less than 1%. The recovery rate was 100.03% and 99.58% for AML and ATV, respectively. The method was also validated for dissolution studies with excellent compatibility.
Conclusion: A new, simple and easy HPLC-UV method was successfully developed and validated for the determination of AML and ATV in both quantification test and dissolution test.
Keywords: Amlodipine, Atorvastatin, Simultaneous, Dissolution, HPLC, Quantification, Volatile buffer
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