Utility of dansyl chloride for the establishment of a sensitive spectrofluorimetric approach for estimating midodrine hydrochloride: application to content uniformity testing.

A new, straightforward spectrofluorimetric approach with high sensitivity was established for determining midodrine hydrochloride based on derivatizing this drug through its reaction with 5-(dimethylamino)naphthalene-1-sulfonyl chloride (dansyl chloride). The highly fluorescent product was extracted with methylene chloride, and then its emission was measured at 532 nm after excitation at 339 nm. The reaction was conducted in aqueous medium containing 0.1 M borate buffer (pH 8.2). The results showed that the proposed method is sensitive with high linearity in the range from 0.1 to 3 µg mL-1. The lower limits of detection and quantitation were 29 and 88 ng mL-1, respectively. Furthermore, the proposed approach was analytically assessed by applying the ICH guidelines. The suggested approach was effectively utilized for the estimation of the medicine in its marketable tablet formulations with excellent recovery and without any interfering effect from excipients. Moreover, the presented approach was utilized to test the content uniformity of commercial tablets following the USP guidelines.

Studying the kinetic of midodrine degradations using TLC stability approach: Application to dosage form and human plasma.

A simple, rapid and selective thin layer chromatographic method has been developed for estimation of the antihypotension drug, midodrine hydrochloride, in pure form, tablet, spiked plasma and artificially degraded samples. Separation was carried out using silica gel 60-F254 as a stationary and mobile phase consisting of methanol: methylene chloride: ammonia in ratio of 8:2:0.2. The detection was carried out at wavelength of 290 nm. The retardation factor was found to be 0.7 and 0.49 for midodrine and its main degradation product desglymidodrine. The method showed linearity for midodrine over a concentration range of 50-1500 ng/spot with good correlation and determination coefficient. The method was applied successfully for analysis of commercial tablets and oral drops with good recovery and without interference of excipients. The method also was applied for studying the stability of the cited drug under different stress conditions including acidic, alkaline, hydrolytic, oxidative and photo- degradations. Furthermore, the kinetic of acidic and alkaline degradations was investigated and the rate constants were found to be 0.620 and 0.074 K h-1 while half life time (t1/2) values were 1.12 and 9.32 h, respectively.

Development of a simple validated spectrofluorometric method for the assay of midodrine in tablets dosage form; Application to content uniformity testing.

A new sensitive spectrofluorimetric technique has been established for the estimation of midodrine hydrochloride. This method depends on the condensation reaction of ortho-phthalaldehyde with the primary aliphatic amine of midodrine in the presence of 2-mercapto-ethanol. The pH of the medium was adjusted to 9.0 using 0.1 M borate buffer. The fluorescence of the product was measured at wavelength of 451 nm after excitation at 334 nm. The method was rectilinear over a concentrations range of 0.1 to 1.5 µg mL-1. The lower detection and quantitation limits were 31 and 94 ng mL-1, respectively. The method was investigated following the guidelines of the International Council of Harmonization. Analysis of commercial tablet dosage form was carried out successfully by the current method with excellent recovery percentages and with no influence from coexisted pharmaceutical additives .This method was used to evaluate the uniformity of the contents of commercial tablets according to the United States Pharmacopoeia.

Approved spectrofluorimetric strategies for assurance of three modern antineoplastic drugs: tepotinib, sotorasib, and darolutamide in their dose forms and biological liquids utilizing mercurochrome.

An approved, straightforward, fast, and delicate spectrofluorimetric strategy was developed for the estimation of tepotinib (TEPO), sotorasib (SOTO), and darolutamide (DARO) as new antineoplastic drugs. The spectrofluorimetric strategy was based on quantitative fluorescence quenching of MER at 538 nm after being excited at 350 nm by the addition of the cited drugs in the presence of acetate buffer (pH 3.5). The degree of fluorescence quenching was directly proportional to the concentrations of the cited drugs within the concentration range of 0.5-10.0, 0.2-10, and 0.4-10.0 µg ml-1 for TEPO, SOTO, and DARO, respectively. Mean ± standard deviation (SD) were calculated for the studied drugs as follows; 99.9 ± 0.87, 99.72 ± 1.08, and 100.21 ± 1.44, for TEPO, SOTO, and DARO, respectively. Limit of detection (LOD) values were 0.16, 0.05, and 0.11 µg ml-1 , whereas limit of quantitation (LOQ) values were 0.5, 0.15, and 0.36 µg ml-1 for TEPO, SOTO, and DARO, respectively. Statistical comparison through detailed strategies produced greater understanding and found that there were no noteworthy contrasts in exactness and exactness between strategies. The proposed strategy was used effectively to analyze the measurement of different forms of the examined drugs. Moreover, the recommended fluorimetric strategy was used for examination of TEPO, SOTO, and DARO in human plasma and urine tests.

Orthophthaldehyde as a fluorescent probe for the feasible and sensitive assay of heptaminol: application to dosage forms and real human plasma.

The antihypotensive drug heptaminol was determined using a spectrofluorimetric method and ortho-phthaladehyde as a fluorescence probe. The drug was mixed with the reagent in the presence of 2-mercaptoethanol and the reaction was carried out in slightly alkaline aqueous solution containing 0.1 M sodium hydroxide. The resulting product exhibited high fluorescence activity that was measured at 451 nm after excitation at 334 nm. The linearity range of the method was 5-100 ng ml-1 with a lower detection limit of 1.8 ng ml-1 . The procedure was evaluated according to the International Council of Harmonization guidelines. The proposed method was applied to analyze the drug in pharmaceutical tablets and oral drops. In addition, the present study represents the first spectrofluorimetric method for the determination of the cited drug in real human plasma. The method provided high recovery percentages without any interference from coexisting pharmaceutical excipients or the components of human plasma.

Combining subsidiary and synchronous approaches for concurrent spectrofluorimetric assurance of lopinavir and ritonavir in tablets utilized in convention for treatment of coronavirus infection (COVID-19) and biological fluids.

In this think about, assurance of lopinavir and ritonavir down to organic concentration level has been carried out. The assurance is based on expanding the selectivity of the spectrofluorimetric procedure by combining both subordinate and synchronous spectrofluorimetric approaches, which allow effective estimation of lopinavir at 248.8 nm and ritonavir at 300.1 nm within the nearness of each other at Δλ of 60 nm. Worldwide Conference on Harmonization approval rules were taken after to completely approve the strategy, and linearity was gotten for the two drugs over the extend of 0.4-2.4 µg mL-1 for Lopinavir and 0.1-0.6 µg mL-1 for ritonavir. Application of of the strategy was successfully carried out within the commercial tablets with great understanding with the comparison strategies. As the detection limits were down to 0.133 and 0.022 µg mL-1 and quantitation limits were 0.395 and 0.068 µg mL-1 for lopinavir and ritonavir, individually; the in vivo assurance of lopinavir and ritonavir in spiked plasma tests was pertinent. The rate recuperations in natural tests were 99.10 ± 0.77 and 99.54 ± 0.60 for lopinavir and ritonavir, individually. Water was utilized as the ideal weakening dissolvable within the proposed strategy which includes an eco-friendly justify.