A fast and green reversed‐phase HPLC method with fluorescence detection for simultaneous determination of amlodipine and celecoxib in their newly approved fixed‐dose combination tablets

Abstract

A fast, green, sensitive, and accurate analytical method using high‐performance liquid chromatography couple with fluorescence detection was established and validated for the simultaneous determination of amlodipine besylate and celecoxib in their recently approved fixed‐dose combination tablets (1:20). Separation of the two drugs was achieved on C18 reversed‐phase column (Thermo ODS Hypersil, 4.6 × 250 mm, particle size 5 µm) using acetonitrile:potassium phosphate buffer (50 mM; pH 5.5, 60:40 v/v) as a mobile phase at 40°C, which eluted at a rate of 1 mL/min. Detection was carried out with excitation and emission wavelengths of 360 and 446 nm for amlodipine and 265 and 359 nm for celecoxib, respectively. The method was linear over a concentration range of 0.05‐2 and 0.05‐10 µg/mL and limit of detection reached to 0.017 and 0.0167 µg/mL for amlodipine and celecoxib, respectively. The developed method was successfully applied to assess the cited drugs in their newly FDA approved fixed‐dose combination tablet dosage form. Furthermore, the method was found to be sensitive and eco‐friendly green alternative to the reported methods as it was evaluated according to the green analytical procedure index tool guidelines and analytical Eco‐Scale.

A novel liquid chromatography‐fluorescence method for the determination of delafloxacin in human plasma

“…Advantages of this mobile phase include a faster and simple preparation and a reduced tendency to precipitate and clog inside the chromatographic system. It is important to mention that, in green chemistry, a new trend when developing novel chromatographic methods is to avoid buffers [24–26]. Gradient and isocratic elutions were also investigated to find the best IS using different fluorescent drugs (difloxacin, marbofloxacin, norfloxacin, enrofloxacin, ciprofloxacin, phenformin, pregnenolone, alfaxalone, and candesartan).…”

“…Contrary to what was expected, only a high concentration of the stock solution of DF was degraded at 30 days, and it may be due to the high amount of DF in the solution. Stability results of QCs of DF have shown stability for 24 h according to European Medicine Agency and FDA [1–31] guidelines, which only recommends storing DF for 24 h without freezing. Freeze‐thaw stability (three cycles) in human plasma [16] has shown stability at –80°C.…”

Quantification and Determination of Stability of Tylvalosin in Pig Plasma by Ultra-High Liquid Chromatography with Ultraviolet Detection

“…Concerning the mobile phases, buffer solutions could cause problems in the LC system, such as clogging in the pump; an acidic mobile phase is one of the best ways to avoid these problems. The current trend in green chemistry is to avoid the use of buffers [ 34 , 35 , 36 ]. Moreover, isocratic elution was selected with a short running time instead of gradient elution.…”

Ecofriendly chromatographic estimation of spasmolytic pharmaceutical mixture along with official toxic impurity, 3,5‐dichloroaniline: Complete green profile appraisal

“…Green chemistry is considered a great challenging approach for introducing reliable, accurate, and effective methods without producing harm or hazard to humans and the environment via using green solvents, minimizing waste production, sample preparation, and energy of the instrument used [1]. Worldwide attention become focused on developing methods which were following the green analytical procedures [2–5].…”