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

Abstract

In this study, the simultaneous determination of bilastine and montelukast, two recently approved co‐formulated antihistaminic medications, was accomplished using a quick, sensitive, environmentally friendly, and reasonably priced synchronous fluorescence spectroscopic approach for the first time. Enhancement of the method's sensitivity down to nanogram levels was achieved by the addition of sodium dodecyl sulfate (1.0% w/v) as a micellar system. According to the results, bilastine and montelukast's fluorescence was measured at 255.3 and 355.3 nm, respectively, using Δλ of 40.0 nm and distilled water as a green diluting solvent. With respect to the concentration ranges of bilastine (5.0–300.0 ng/ml) and montelukast (50.0–1000.0 ng/ml), the method showed excellent linearity (r ≥ 0.9998). The results showed that the suggested method is highly sensitive, with detection limits of 1.42 and 13.74 ng/ml for bilastine and montelukast, respectively. Within‐run precisions (intra‐ and interday) per cent relative standard deviations (RSD) for both analytes were <0.59%. With high percentage recoveries and low percentage RSD values, the designed approach was successfully applied for the simultaneous estimation of the cited medications in their dosage form and human plasma samples. To evaluate the green profile of the suggested method, an analytical GREENNESS metric approach (AGREE) and green analytical procedure index (GAPI) metric tools were used. These two methods for evaluating greenness confirmed that the developed method met the highest number of green requirements, recommending its use as a green substitute for the routine analysis of the studied drugs. The proposed approach was validated according to ICHQ2 (R1) guidelines.

A highly sensitive spectrofluorimetric method for the determination of bilastine in human plasma: Application of content uniformity testing

“…Although four spectrofluorimetric analytical approaches [9][10][11][12] were prescribed for estimating bilastine in its pure form and in tablets [9], there is only one reported approach for estimating it in human plasma by synchronous fluorimetry technique [12].…”

“…Through extensive literature review, various analytical techniques have been developed to analyze bilastine in both bulk form and pharmaceutical formulations. These techniques include spectrophotometric [6][7][8], spectrofluorimetric [9][10][11][12], high-performance liquid chromatographic [13][14][15][16][17][18][19], high-performance thin-layer chromatographic [20], near-infrared spectroscopic [21], and electrochemical methods [22].…”

“…These methods have certain limitations, including a narrow calibration concentration range [9] and the use of highly hazardous solvents such as 1.0 M sulfuric acid [10]. In addition, two spectrofluorimetric methods have been recently reported for determination of bilastine in its mixture with montelukast by using synchronous technique [11,12]. The detection limits of the previously reported fluorometric methods were ranging from 0.33 to 10.9 ng/mL.…”

A green, fluorescent probe employing erythrosine-B for tracing the accidental administration of levamisole in milk and plasma samples

“…The significance of spectrofluorimetry for the determination of various pharmaceuticals in different matrices could be illustrated by reviewing early reported methods in the literature. 17–26…”