Integrated resonance Rayleigh scattering approach utilizing Box-Behnken experimental design for the facile quantification of prucalopride in pharmaceutical tablets and human urine with sustainability assessment.

Prucalopride (PCP) is one of the recent drugs used for the regulation of gastrointestinal tract motility and the treatment of constipation. A new, highly sensitive and fast resonance Rayleigh scattering (RRS) approach was suggested for PCP determination. The approach was based on its reaction of PCP with eosin Y in buffered medium (pH 3.5) to form an ion pair association complex which had a significant enhancement in RRS compared to that of eosin Y or PCP alone. The enhancement of RRS intensity had straight correlation to PCP concentration ranging from 150 to 2000 ng mL-1 with 38 ng mL-1 as LOD and 125 ng mL-1 as LOQ. The measurements were done at a wavelength of 365 nm that provided the maximum sensitivity. All the experimental parameters were studied carefully and optimized via Box-Behnken experimental design. The International Council for Harmonization (ICH) guidelines were employed to validate the suggested method and the obtained results proved the appropriate method performance. The method was efficiently utilized to determine PCP in pure form, pharmaceutical tablets and spiked urine samples with no interferences from the surrounding matrices. Furthermore, the greenness of the suggested procedure was confirmed using different green metric approaches.

Sensitive spectrofluorimetric determination of the prokinetic drug prucalopride succinate based on supramolecular aggregation approach with evaluation of method greenness: application to content uniformity test.

The prokinetic drug, prucalopride (PCP) succinate, was determined using a new spectrofluorimetric approach with a highly sensitive, rapid, and simple procedure. The method exploited the enhancement of the inherent native fluorescence of PCP by micellar aggregation with sodium lauryl sulfate (SLS) as an anionic surfactant. Different factors that could affect the fluorescence intensity were carefully studied in order to achieve the maximal fluorescence signal. Measurement of the enhanced fluorescence was done at 354 nm after the excitation at 276 nm. The fluorescence intensity-concentration plot was rectilinear in the concentration range of 50-600 ng/ml with detection and quantitation limits of 13.9 and 42.1 ng/ml, respectively. The method underwent validation according to the International Council for Harmonisation criteria in order to assess its analytical performance, and promising results were achieved that proved the validity and reliability of the method. Furthermore, the method was employed effectively for the analysis of the cited drug in commercial pharmaceutical tablets.

An innovative validated spectrofluorimetric method for determination of Lisinopril in presence of hydrochlorothiazide; application to content uniformity testing.

A new sensitive and discriminating spectrofluorimetric method has been developed and validated for determination of Lisinopril, one of the angiotensin converting enzyme inhibitors, in its pure bulk form and pharmaceutical tablets. The reaction of Lisinopril with ethylacetoacetate and formaldehyde in acidic buffered medium (pH3.8) has yielded a pale yellow product that exhibited a high fluorescence measured at 438nm after excitation at 350nm. All the experimental parameters affecting the formation and stability of the produced fluorophore were carefully investigated and optimized to give the maximum sensitivity. The fluorescence intensity was directly proportional to the drug concentration in the range of 0.5-4.5µg/mL with a limit of detection equal to 0.16µg/mL. The method was successfully applied in the analysis of the commercially available pharmaceutical tablets containing the single drug or its binary mixtures with Hydrochlorothiazide. Furthermore, the developed procedure was adapted for studying the content uniformity test of some dosage forms containing the cited drug.

Switch on fluorescence probe for the selective determination of lisinopril in pharmaceutical formulations: application to content uniformity testing.

Lisinopril, an ACE inhibitor, was selectively determined in pharmaceutical products using spectrofluorimetry. The method was based on the switch on fluorescamine fluorescence as a result of its interaction with the primary amino group of the drug in the presence of aqueous borate buffer (pH 9.5). The fluorescence emission was measured at 475 nm after excitation at 390 nm. The fluorescent product was suggested to be a diaryl pyrrolone cation which has a coplanar structure. Different experimental conditions affecting the reaction were optimized to give the maximum sensitivity. The fluorescence intensity was linear with the drug concentration in the range of 0.55-4.5 µg mL-1. The method was validated according to ICH guidelines and the result was acceptable. The calculated limits of detection and quantitation were 0.182 and 0.55 µg mL-1, respectively. The commercially available dosage forms containing lisinopril alone or in combination with hydrochlorothiazide were effectively analyzed by the proposed method. The obtained results were in agreement with those of the reported method in respect to accuracy and precession. Moreover, the suggested method was employed to determine the content uniformity testing of the investigated dosage forms.

Selective spectrofluorimetric method for determination of Lisinopril in pharmaceutical preparations and in presence of hydrochlorothiazide: Application to content uniformity testing.

A novel sensitive and cost-effective spectrofluorimetric method has been developed and validated for determination of lisinopril (an angiotensin converting enzyme inhibitor) in its pure form and pharmaceutical preparations. The method is based on the reaction of the drug with ninhydrin and phenylacetaldehyde in buffered medium (pH 7.0) to form a highly fluorescent product measured at 460 nm after excitation at 390 nm. Different experimental parameters were optimized and calibration curve was constructed. The fluorescence-concentration relationship was linear in the range of 0.15-4.0 µg mL-1 . The calculated Limit of detection (LOD) and Limit of quantitation (LOQ) were 0.04 and 0.12 µg mL-1 , respectively. The method was successfully applied for the analysis of pharmaceutical preparations containing the studied drug either alone or co-formulated with hydrochlorothiazide. The obtained results were in agreement with those of the reported method in respect to accuracy and precession. Moreover, the method was applied content uniformity testing according to United States Pharmacopeia (USP) guidelines.