Determination of midodrine hydrochloride via Hantzsch condensation reaction: a factorial design based spectrophotometric approach

El-Azazy, Marwa

doi:10.1039/c5ra05465f

Cited by 27 publications

(22 citation statements)

References 22 publications

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“…Various methods have reported using chromatographic, electrochemical and spectrophotometric methods to determine midodrine in its pharmaceutical preparations and in biological fluids. The proposed method is the first spectrofluorimetric method used to determine midodrine in its pharmaceutical preparations.…”

Section: Introductionmentioning

confidence: 99%

The convenient use of fluorescamine for spectrofluorimetric determination of midodrine hydrochloride in pure form and its tablets formulation: Application to content uniformity testing

2018

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A novel sensitive and simple spectrofluorimetric method was developed then validated for determination of midodrine in both its authentic pure form and its tablets. This method is based on the reaction between midodrine's aliphatic primary amine moiety with fluorescamine reagent, using borate buffer at pH 7.8 and yielding a highly fluorescent product whose fluorescence intensity was measured at 462 nm after excitation at 388 nm. This method represents the first attempt for determination of midodrine spectrofluorimetrically. A calibration curve was constructed showing that the linear range was 0.2–3.0 μg/ml. The limit of detection and limit of quantitation values were 0.06 and 0.19 μg/ml respectively. The correlation coefficient (r) and the determination coefficient (r2) values were 0.9992 and 0.9984 respectively. The proposed method was validated according to ICH guidelines and successfully applied for determination of midodrine in its tablets with an overall % recovery of 99.56 ± 0.95. Finally, the presented method was adapted to study the content uniformity test according to United States Pharmacopeia guidelines.

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Section: Introductionmentioning

confidence: 99%

The convenient use of fluorescamine for spectrofluorimetric determination of midodrine hydrochloride in pure form and its tablets formulation: Application to content uniformity testing

2018

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“…Another approach to perform LOF test is to find the probability, p-value. Having a p-value higher than 0.05 means that the lack of fit is not significant [29,30].…”

Section: Assessment Of Performance: Model Metricsmentioning

confidence: 99%

Analytical Calibrations: Schemes, Manuals, and Metrological Deliberations

El-Azazy¹

2018

Calibration and Validation of Analytical Methods - A Sampling of Current Approaches

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Chemical measurement processes (CMPs) must be performed in a setup of controlled statistical conditions. Thus, validation of such a measurement process and assessment of its ability to accurately measure the analyte is important. Analytical calibration is the most crucial step in any analytical procedure targeting the estimation of analyte concentration. As a key component of any validation procedure, calibration must be properly conducted. To achieve that, firm knowledge with the realms of the calibration process must exist. Several jurisdictions help to build up this acquaintance, including the terminology and definitions, the international guidelines and how they differ, schemes and manuals to be used to build a calibration model, metrological considerations, and assessment procedures. Careful thinking prior to any of the previous calibration aspects is necessary and helps to improve the product of the calibration process. Throughout this chapter, aspects of the calibration assembly will be thoroughly discussed. Different types of calibration will be revealed with a focus on analytical calibration for a CMP. Steps for a successful calibration will be described. The reader will be able to use information given throughout this chapter as a guide for an effective calibration process.

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“…Target Table 3. Screened factors and response domains for a two-level ( 2 4 ) full factorial design (FFD) premeditated for Hantzsch reaction (reproduced from author's own work [38] with permission from the Royal Society of Chemistry). Additionally, the overlaying process is not that practicable as the best regions for each response are a bit far from each other.…”

Section: Spectroscopic Analyses -Developments and Applicationsmentioning

confidence: 99%

“…Direct application of spectrophotometric analysis is only possible if the selected wavelength is not affected by another concomitant analyte. As an approach, application of spectrophotometry entails a study of a variety of factors affecting a single response or multiple responses [37][38][39].…”

Section: Spectrophotometrymentioning

confidence: 99%

“…Variables proved to be significant (p < 0.05) were warily attuned utilizing a response surface methodology (RSM) with a face-centred central composite design. The suggested model represented a perfect example for probing the efficiency of factorial designs in optimizing the reaction conditions and maximizing the output [38]. Statistical validation of the proposed technique was performed by using ANOVA in two successive steps.…”

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confidence: 99%

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Factorial Design and Machine Learning Strategies: Impacts on Pharmaceutical Analysis

El-Azazy¹

2017

Spectroscopic Analyses - Developments and Applications

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Pharmaceutical analysis is going through an expeditious progress as the perception of 'multivariate data analysis' (MVA) becomes gradually more assimilated. Pharmaceutical analysis comprises a range of processes that covers both chemical and physical assessment of drugs and their formulations employing different analytical techniques. With the revolution in instrumental analysis and the huge amount of information produced, there must be an up-to-date data processing tool. The role of chemometrics then comes up. Multivariate analysis (MVA) has the capability of effectively drawing a complete picture of the investigated process. Moreover, MVA reproduces the arithmetic influence of variables and their interactions through a smaller number of trials, keeping both efforts and capitals. Spectrophotometry is among the most extensively used techniques in pharmaceutical analysis either direct (single component) or derivative (multicomponent). In addition to these recognized benefits, using chemometrics in conjunction with spectrophotometry affects three vital characteristics: accuracy, precision and robustness. The impact of hyphenation of spectrophotometric analytical techniques to chemometrics (experimental design and support vector machines) on analytical laboratory will be revealed. A theoretical background on the different factorial designs and their relevance is provided. Readers will be able to use this chapter as a guide to select the appropriate design for a problem.

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Determination of midodrine hydrochloride via Hantzsch condensation reaction: a factorial design based spectrophotometric approach

Abstract: An experimental design was adopted for determination of MD·HCl. The novelty of the current approach arises from being multivariate compared to traditional univariate techniques.

Cited by 27 publications

References 22 publications

The convenient use of fluorescamine for spectrofluorimetric determination of midodrine hydrochloride in pure form and its tablets formulation: Application to content uniformity testing

The convenient use of fluorescamine for spectrofluorimetric determination of midodrine hydrochloride in pure form and its tablets formulation: Application to content uniformity testing

Analytical Calibrations: Schemes, Manuals, and Metrological Deliberations

Factorial Design and Machine Learning Strategies: Impacts on Pharmaceutical Analysis

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