Biorelevant and quality control dissolution method development and validation of quetiapine fumarate tablets

Taskeen, Muhsina; Tirunagari, Mamatha; Qureshi, Husna Kanwal

doi:10.23893/1307-2080.aps.0552

Cited by 3 publications

(2 citation statements)

References 7 publications

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“…Dissolution is an important test in formulation development studies and is conducted in order to determine a drug's dosage for properties. Dissolution is an official test that is commonly used as a predictor of in vivo performance that is simulated to evaluate the performance of solid dosage forms, transdermal patches, and suspensions, and it is routinely used in quality control (QC) and research and development (R&D) studies [11]. In the case of generic product development (Favipiravir 200 mg Tablets) in the Abdi Ibrahim Research & Development laboratory, these studies need to be performed for a comparison with the reference product (Avigan Tablets 200 mg ® ).…”

Section: Introductionmentioning

confidence: 99%

The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

Göktuğ¹,

Altaş²,

Kayar³

et al. 2021

Sci. Pharm.

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The aim of this study was to develop and validate a dissolution test for favipiravir release in a tablet dosage form using ultra-high performance liquid chromatography (UHPLC). The dissolution method was developed by testing the solubility of favipiravir in media with different pH values. The results demonstrated that the best dissolution was achieved in phosphate buffer with a pH of 6.8. The amount of favipiravir that was released was about 100% after 30 min. The UHPLC method presented linearity (R = 1.000) in the concentration range of 0.044–0.44 mg/mL. The recovery parameter that was achieved ranged from 102.5% to 104.2%. The system suitability, repeatability, and intermediate precision RSD% results were found to be 0.36%, 1.99%, and 2.49%, respectively. In addition to these parameters and results, an F-test was performed using the Minitab 18 Statistical Software program for the intermediate precision and repeatability results. The standard and sample solutions were found to be stable for 2 days in their respective dissolution medium. This analytical method was also found to be selective for favipiravir. In conclusion, a simple and feasible dissolution method with a short run time of 2.5 min was developed and validated successfully. The obtained results demonstrated that the dissolution test developed here is adequate for its purpose and can be applied as the dissolution method for favipiravir in film-coated tablets for release analyses.

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Section: Introductionmentioning

confidence: 99%

The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

Göktuğ¹,

Altaş²,

Kayar³

et al. 2021

Sci. Pharm.

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“…QF is an antipsychotic drug for treating schizophrenia and the chemical structure is shown in Figure . QF is administered twice a day and the problem of patients skipping doses has been reported in most cases . Hence, the need for a delivery system for QF that could offers extended release (ER), minimize side effects due to over‐dosage with improve compliance in schizophrenia patients and in which QF does not have any chemical interactions with the hydrogel matrix.…”

Section: Resultsmentioning

confidence: 99%

pH‐Responsive Studies of Bacterial Cellulose /Chitosan Hydrogels Crosslinked with Genipin: Swelling and Drug Release Behaviour

et al. 2019

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Semi interpenetrating hydrogels (semi-IPN) of bacterial cellulose (BC) and chitosan (Ch) crosslinked with genipin were prepared and characterised using Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR) and Scanning Electron Microscopy (SEM). Infrared spectra showed amide I and II absorption peaks at 1632 and 1554 cm À 1 and CÀ N stretching absorptions at 1250 and 1020 cm À 1 , respectively, for crosslinked hydrogels. The fibrous structure of BC and the porosity in the hydrogels were revealed by SEM. Swelling of hydrogels was sensitive to pH, and maximum at pH 1.0. Swelling of non-crosslinked samples decreased as the pH increased. However, with crosslinked hydrogels, swelling increased as chitosan ratio increased at low pH, as well as with increase in BC ratio at high pH. Free, bound and intermediate water types in hydrogels were revealed by DSC. The release kinetics of Quetiapine fumarate (QF), an antipsychotic drug used for the treatment of Schizophrenia was studied using UV spectrometry, followed predominantly, the Higuchi model at all pH for crosslinked hydrogels. The transport mechanism of hydrogels was a combination of non-Fickian and Super Case II. Crosslinked hydrogels showed controlled drug release behaviour. These hydrogel systems possess potential application in pharmaceutical field as all chemicals used in the development of the hydrogels are non-toxic, with BCÀ Ch 60:40 showing most promising potential.[a] J.

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Quetiapine Fumarate: A Review of Analytical Methods

Hamsa¹,

Kariyarambath³

et al. 2022

Journal of Chromatographic Science

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Atypical antipsychotics are newer second-generation antipsychotics with weak dopamine type 2 blocking but potent 5-HT2 antagonistic activity. They are considered first-line treatments for schizophrenia and gradually replace typical antipsychotics. Extrapyramidal side effects are minimal, and they tend to improve impaired cognitive function in psychotics. Quetiapine fumarate is an atypical antipsychotic drug used to treat schizophrenia, mania and depression in people with bipolar disorder combined with other drugs or alone. Quetiapine was developed in 1985 and approved for medical use in the USA in 1997. Thorough computer-aided literature, surveys revealed that numerous analytical methods were reported over the years. The present study reviews analytical methods with their validation parameters published during the last 22 years (1999–2021) either as a single entity or combination in dosage form, and determination from biological samples. Novel strategies for increasing separation quality, such as QbD analysis and green spectroscopy, were discovered during the evaluation, and this review can be utilized for further research reference.

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Biorelevant and quality control dissolution method development and validation of quetiapine fumarate tablets

Cited by 3 publications

References 7 publications

The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

The Development and the Validation of a Novel Dissolution Method of Favipiravir Film-Coated Tablets

pH‐Responsive Studies of Bacterial Cellulose /Chitosan Hydrogels Crosslinked with Genipin: Swelling and Drug Release Behaviour

Quetiapine Fumarate: A Review of Analytical Methods

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