Green quality by design HPLC approach for the simultaneous determination of Bilastine and Montelukast

Abstract

For the simultaneous estimation of two co-formulated antihistaminic drugs (Bilastine and Montelukast), a novel and eco-friendly reversed-phase HPLC approach with both diode array and fluorescence detection modes was designed. Rather than using the routine methodology, the Quality by Design (QbD) approach was adopted to speed up the method development and to test robustness of the method. To evaluate the effect of variable factors on chromatographic response, a full factorial design was used. The chromatographic separation was performed using isocratic elution on the C18 column. The mobile phase consists of 92% methanol, 6% acetonitrile, and 2% phosphate buffer with 0.1 (v/v) triethylamine adjusted to pH 3, it was pumped at a flow rate of 0.8 mL/min with an injection volume of 20 μL. The developed stability indicating HPLC approach was used to assess the stability of montelukast (MNT). It was subjected to a variety of stress conditions, including hydrolytic (acid–base), oxidative, thermal, and photolytic stress conditions. All of these conditions were found to have relevant degradation pathways. Under the described experimental conditions, MNT degradation followed pseudo-first-order kinetics. The kinetic parameters of its degradation (rate constant and t1/2) were calculated and a proposal for the degradation pathway was postulated.

A highly sensitive micelle‐enhanced synchronous spectrofluorimetric determination of the recently approved co‐formulated drugs, bilastine and montelukast in pharmaceuticals and human plasma at nanogram levels

“…The designed approach provides, for the first time, a highly sensitive, rapid, easy‐to‐use, environmentally friendly, and reasonably priced spectrofluorimetric methodology depending on SFS for the simultaneous analysis of BIL and MTK in plasma and dosage forms without needing significant quantities of hazardous organic solvents or intricate equipment as in the reported chromatographic methods. The proposed method also has higher sensitivity compared with the reported HPLC [8] and spectrophotometric [34] methods. Additionally, the analytical GREENNESS metric approach (AGREE) and green analytical procedure index (GAPI) were successfully used to assess the developed approach's green profile, demonstrating the excellent greenness of the suggested method [35, 36].…”

“…From the literature, different methods were reported for the determination of BIL and MTK either separately or simultaneously, including the high‐performance liquid chromatography (HPLC) [4–8], high‐performance thin layer chromatography (HPTLC) [9, 10], and UV–visible spectrophotometry [11, 12]. To date, no spectrofluorimetric approaches have been reported for the concurrent estimation of the studied drugs.…”

“…From the literature, different methods were reported for the determination of BIL and MTK either separately or simultaneously, including the high-performance liquid chromatography (HPLC) [4][5][6][7][8],…”

Optimization of chromatographic conditions via Box‒Behnken design in RP-HPLC-PDA method development for the estimation of folic acid and methotrexate in bulk and tablets

“…The capacity and efficacy of a typical UV–Vis spectrophotometer with a single channel detector were found to be constrained. This sparked interest in discovering new methods that may be used to replace UV spectrophotometers [ 24 , 25 ].…”