A facile on–off fluorescence approach for fluvoxamine determination in pharmaceutical tablets; application to content uniformity testing† † Electronic supplementary information (ESI) available. See DOI: https://doi.org/10.1039/d3ra08257a
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SUBMITTER: Derayea S
PROVIDER: S-EPMC10926349 | biostudies-literature | 2024 Mar
REPOSITORIES: biostudies-literature
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Project description:ObjectivesChildren requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative formulation.MethodsHydrocortisone 10 mg tablets were quartered by four different operators using a standard pill splitter. Hydrocortisone 2.5 mg mini-tablets (3 mm diameter) were formulated using a wet granulation method and manufactured using a high-speed rotary press simulator. The weight and content uniformity of the quartered tablets and mini-tablets were assessed according to pharmacopoeial standards. The physical strength and dissolution profiles of the mini-tablets were also determined.ResultsMore than half of all quartered 10 mg tablets were outside of the ±10% of the stated US Pharmacopoeia hydrocortisone content (mean 2.34 mg, SD 0.36, coefficient of variation (CV) 15.18%) and more than 40% of the quartered tablets were outside the European Pharmacopoeia weight variation. Robust mini-tablets (tensile strengths of >4 MPa) were produced successfully. The mini-tablets passed the pharmacopoeial weight and content uniformity requirements (mean 2.54 mg, SD 0.04, CV 1.72%) and drug release criteria during in vitro dissolution testing.ConclusionThis study confirmed that quartering 10 mg hydrocortisone tablets produces unacceptable dose variations and that it is feasible to produce 3 mm mini-tablets containing more accurate doses for paediatric patients.
| S-EPMC5843003 | biostudies-literature
Project description:Green analysis has turned out to be of a great value in all areas, including pharmaceutical analysis. Thus, it is extremely important to consider the environmental influence of each step in developing any analysis technique. The present work illustrates a validated, simple and green spectrofluorimetric method for the analysis of dantrolene sodium (DAN). The developed process is characterized by being of high sensitivity as well as being relatively inexpensive. The suggested technique based on the formation of a highly fluorescent product of DAN via its reduction by the aid of Zn/HCl system. The resulting fluorophore showed a powerful fluorescence at λ em 344 nm after excitation at λ ex 279 nm. Calibration graph revealed a great linear regression (r = 0.9998) within concentration ranging from 0.05 to 2.0 µg ml-1. The suggested method had very low detection and quantification limits of 0.010 and 0.031 µg ml-1, respectively. The applied technique was effectively used in the determination of DAN in its pharmaceutical preparations. The results were compared with those from using the official United States Pharmacopeia (USP) method and they were in a good agreement. Moreover, content uniformity testing of DAN in capsules was performed adopting the investigated technique with satisfying results. The greenness of the suggested technique was confirmed by the three standard assessment tools. Therefore, the developed technique can be used in the routine quality control analysis of DAN with minimum harmful impact on nature or individuals.
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Project description:Raman spectroscopy has proven valuable for determining the composition of manufactured drug products, as well as identifying counterfeit drugs. Here we present a simple method to determine the active pharmaceutical ingredient (API) mass percent in a sample that does not require knowledge of the identities or relative mass percents of the inactive pharmaceutical ingredients (excipients). And further, we demonstrated the ability of the method to pass or fail a manufactured drug product batch based on a calculated acceptance value in accordance with the US Pharmacopeia method for content uniformity. The method was developed by fitting the Raman spectra of 30 Claritin® tablets with weighted percentages of the Raman spectrum of its API, loratadine, and a composite spectrum of the known excipients. The mean loratadine mass of 9.79 ± 40 mg per 100 mg tablet compared favorably to the 10.21 ± 0.63 mg per 100 mg tablet determined using high-performance liquid chromatography, both of which met the acceptance value to pass the 10 mg API product as labelled. The method was then applied to a generic version of the Claritin product that employed different excipients of unknown mass percents. A Raman spectrum representative of all excipients was created by subtracting the API Raman spectrum from the product spectrum. The Raman spectra of the 30 generic tablets were then fit with weighted percents of the pure loratadine spectrum and the created excipient spectrum, and used to determine a mean API mass for the tablets of 10.12 ± 40 mg, again meeting the acceptance value for the 10 mg API product. The data suggest that this simple method could be used to pass or fail manufactured drug product batches in accordance with the US Pharmacopeia method for content uniformity, without knowledge of the excipients.
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Project description:Chlorphenoxamine hydrochloride is a chemical that has attracted interest because of its notable anti-histaminic and anti-cholinergic characteristics. Moreover, it has been recognized as a highly efficient tool in the fight against several lethal viral diseases, such as Severe Acute Respiratory Syndrome Coronavirus. In this study, five efficient and straightforward univariate spectrophotometric approaches are proposed for accurately measuring the quantities of Caffeine and Chlorphenoxamine HCl in bulk forms and combined pharmaceutical formulations. Notably, these methods based on an advanced approach using the factorized response spectrum and not require any initial processing.They have been classified into three spectrophotometric platform windows. The study of Window I focuses on absorption spectra of substances in their original states(zero-order). It includes, absorbance resolution method (AR), extended absorbance difference method (EAD), and factorized zero order method (FZM). Window II focuses on the factorized derivative method (FDM), while Window III focuses on factorized ratio difference method (FRM). These approaches successfully measured concentration of Caffeine and Chlorphenoxamine HCl within a range of 3-35.0 and 3-45.0 μg/mL, respectively. The factorized response spectrum's exclusivity stems from its capacity to fully separate the mentioned components in mixture and recover the pure spectra. Validation of the suggested approaches has been conducted according to guidelines established by International Council for Harmonization, which demonstrated acceptable levels of accuracy and precision. The scope of this work has been expanded to include verification of content uniformity of dosage units according to recommendations outlined in United States Pharmacopoeia. Greenness profile of the proposed approaches has been properly assessed using state-of-the-art software metrics, in comparison to the reported one. Finally, the proposed methods demonstrated strong compliance with the recently established principles of white field of analytical chemistry.
| S-EPMC11923055 | biostudies-literature
Project description:Herbal medicines currently represent an important part of the world pharmaceutical market, which shows growing interest in the use of herbal medicines. However, the production of such medicines involves a complex series of steps, which determine the production viability and the quality of the final product. Ximenia americana L. is a plant occurring in several regions of the world, with well-known and applied medicinal properties. Thus, the aim of this work was to develop and evaluate the physical and physical-chemical quality of tablets produced with X. americana L. extract. The extract was spray-dried from a hydroethanolic extractive solution and characterized as to its phytochemical composition. The chemical marker was determined and quantified using validated chromatographic methods. These methods indicated the presence of gallic acid at a concentration of 1.61 mg g(-1). Formulations were proposed and analyzed for their flow and compaction properties. The best formulation was used to obtain a batch of tablets, which was evaluated for its quality characteristics and showed to be within the pharmacopoeial specifications for average weight, hardness, friability, and disintegration time. The dissolution profile of the tablets produced was obtained, showing the release of about 70% of the vegetable extract content within 30 minutes. Results showed that it was possible to obtain herbal tablets containing a high content of vegetal extract by direct compression, developing a rapid process of formulation and production and guaranteeing the quality characteristics of the final product.
| S-EPMC5993115 | biostudies-literature
Project description:Duloxetine is an antidepressant that exhibits its action by preventing the reuptake of serotonin and norepinephrine by neurons. In this analytical study, we developed two facile, sensitive methods for duloxetine analysis. Both methods rely on the formation of binary association complex between erythrosine-B and duloxetine in an acidic medium using spectrofluorimetric and resonance Rayleigh scattering (RRS) techniques. Spectrofluorimetric method simply uses the quenching property of the formed complex on the native fluorescence of erythrosine-B at an emission wavelength of 557.2 nm (λ ex = 528.6), while RRS is based on detecting the enhancement in the RRS signal at 357.2 nm. The proposed methods have been validated according to the International Conference on Harmonization guidelines. The approaches provide linear assay of duloxetine hydrochloride over 0.1-2.4 µg ml-1 and 0.2-2.0 µg ml-1 for spectrofluorimetric and RRS methods, respectively. Variables affecting methods and complex formation were studied and optimized. The limit of detection values were 0.03 and 0.056 µg ml-1 for spectrofluorimetric and RRS methods, respectively. Both approaches were applied with acceptable results for formulation analysis and evaluation of cymbatex capsule content uniformity.
| S-EPMC8479336 | biostudies-literature
Project description:Ecological, sensitive, fast and economic approaches are the main aspects in quality control of pharmaceutical products. Elagolix (ELG) is an orally non-peptidic GnRH antagonist, recently approved drug by Food and drug administration in 2018 for treatment of pain associated with endometriosis. A green, and sensitive method was developed and validated for determination of ELG based on micellar spectrofluorometric approach. Many factors were studied to enhance the fluorescence intensity of ELG and the highest sensitivity was obtained upon using 1% Sodium dodecyl sulphate (SDS) at 438 nm after excitation at 270 nm. A linear relationship was obtained over a range of 50-1000 ng mL-1 between ELG concentration and corresponding fluorescence intensity. The developed method was validated according to ICH guidelines and successfully applied for testing the content uniformity and determination of ELG in pharmaceutical dosage forms with percentage recovery 99.31 ± 1.98. Furthermore, the capability of the method due to its high sensitivity to determine ELG in human plasma with percentage recoveries in a range of 98.54-100.46. The greenness of the method was investigated using three different approaches; Analytical Procedure Index (GAPI), Analytical Eco-Scale and Analytical Greenness Metric (AGREE).
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Project description:A validated, sensitive, and simple spectrofluorimetric method was developed for the analysis of two important CNS-acting drugs, olanzapine and diazepam, in their commercial tablets without the need for any pretreatment steps. The developed method relied on the quantitative quenching effect of each of olanzapine and diazepam on the native fluorescence of nitrogen and sulfur-doped carbon quantum dots (NS@CQDs). NS@CQDs were prepared from thiosemicarbazide and citric acid by a facile one-pot hydrothermal technique. The synthesized NS@CQDs were characterized by different spectroscopic and microscopic techniques. NS@CQDs produced a maximum emission peak at 430 nm using 360 nm as an excitation wavelength. Calibration curves showed a good linear regression over the range of 5.0-200.0 and 1.0-100.0 μM with detection limits of 0.68 and 0.29 μM for olanzapine and diazepam, respectively. The adopted method was used for the determination of the investigated drugs in their tablets with high % recoveries (98.84-101.70%) and low % RSD values (< 2%). As diazepam is one of the most commonly abused benzodiazepines, the developed method was successfully applied for its determination in spiked human plasma with high % recoveries and low % RSD values, providing further insights for monitoring its potential abuse. The quenching mechanism was also studied and confirmed to be through dynamic and static quenching for olanzapine and diazepam, respectively. Due to the high selectivity and sensitivity, content uniformity testing of low-dose tablets was successfully performed by applying the United States Pharmacopoeia guidelines. The method's validation was performed in compliance with ICHQ2 (R1) recommendations.
| S-EPMC9667599 | biostudies-literature
Project description:In the present paper, three electrodes were prepared with the aim of detecting chromium (III) in pharmaceutical tablets and comparing their capabilities and efficiency. At first, N-(pyridine-2-ylcarbamothioyl) benzamide (NP2YCTB) was synthesized and characterized by 1H NMR, FTIR, and 13C NMR spectroscopy methods. Then, it is used as a sensing material to prepare three types of chromium potentiometry sensors including solid-state electrodes (SSE), coated wire electrodes (CWE) as asymmetric electrodes, and liquid membrane electrodes (LME) as symmetric electrodes. The responses of all electrodes were Nernstian. Field-emission scanning electron microscopy was utilized to investigate the liquid membrane morphology. The presence of chromium (III) in the membrane was proved using Energy-dispersive X-ray spectroscopy and the coordination of NP2YCTB heteroatoms with chromium (III) was confirmed by Fourier transform infrared spectroscopy. The limit of detection for SSE (3 × 10-9 mol/L) was enhanced compared with LME (7 × 10-6 mol/L) and CWE (3 × 10-7 mol/L). The response time of electrodes was very short so it was about 5-6 s for LME and CWE and 5-8 s for SSE. The sensors were used for the potentiometric determination of chromium (III) in pharmaceutical tablets and in the potentiometric titration of it with EDTA.
| S-EPMC10731092 | biostudies-literature
Project description:A quantitative nuclear magnetic resonance (qNMR) method to measure the content of Orlistat in tablets was studied and found to be efficient, accurate, reliable, and simple. In this paper, phloroglucinolanhydrous and dimethylsulfoxide-d₆ (DMSO-d₆) served as the internal standard and solvent, respectively. The qNMR methodology, including the linearity, range, the limit of detection (LOD) and quantification (LOQ), stability, precision, and accuracy, was validated seriatim, and the results were very favorable. The content determination results of three batches of Orlistat in tablets were almost identical upon comparing the qNMR method and the high-performance liquid chromatography (HPLC) method. The recommended method authentically compensated the deficiencies of the current HPLC method for determining Orlistat content, and proved to be a method complementary to traditional analysis for the purity measurement of Orlistat in some pharmaceutical preparations.
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