Filters in Dissolution Testing: Evaluation and Selection

Smith, J.S.; George, Jesmi; Nadler, Timothy; Joshi, Vivek

doi:10.14227/dt270420p6

Cited by 7 publications

(8 citation statements)

References 14 publications

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“…The United States Pharmacopoeia monographs on dissolution testing emphasize that the analysis of filtered samples should be performed because the sample may contain active substances and undissolved excipients at any time during the test. Therefore, filtration is considered a critical step before performing any subsequent analysis (USP, 2019; Smith et al, 2020).…”

Section: Resultsmentioning

confidence: 99%

Validation of a UV spectrophotometric method to quantify losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8

Araujo-Fernandez¹,

Uribe-Villarreal²,

Perez-Chauca³

et al. 2022

J Pharm Pharmacogn Res

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Context: The validation of a method is synonymous with the quality of the obtained results. The dissolution test is an analytical technique to evaluate the quality and stability of drugs during their development. Aims: To evaluate whether the UV spectrophotometric method for the quantification of losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8 meet with the validation parameters. Methods: The determination and evaluation of validation parameters were carried out under the guidelines of the regulatory entities. Linearity and range, accuracy, precision, specificity, limits of detection and quantification, robustness, stability of the sample solution were evaluated, and the filter test was added. All data obtained were subject to an analysis of variance and t-student analysis with a confidence level of 95% (α = 0.05). Results: The UV spectrophotometric method meets the acceptance criteria for each validation parameter. Likewise, it was identified that the prepared solutions were stable at pH 6.8 for 24 hours; however, they were not stable at pH 1.2 and 4.5. Conclusions: The method meets with the validation criteria and is suitable to be used for quantifying samples obtained from the losartan potassium tablet dissolution test.

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Section: Resultsmentioning

confidence: 99%

Validation of a UV spectrophotometric method to quantify losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8

Araujo-Fernandez¹,

Uribe-Villarreal²,

Perez-Chauca³

et al. 2022

J Pharm Pharmacogn Res

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“…The dissolution filter can be a culprit in dissolution issues, with missing or only partial filter validation completed (17). Filter validation should ensure that the discard volume is established correctly and is performed at the lowest concentration expected in the dissolution profile (e.g., the first timepoint at the lowest strength).…”

Section: Filtersmentioning

confidence: 99%

Dissolution Method Troubleshooting: An Industry Perspective

Mann¹,

Hermans²,

Contrella³

et al. 2022

Dissolution Technol.

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Quality control dissolution testing represents a key product performance test for solid oral dosage forms and is the most likely QC test to result in laboratory investigations because of the relatively complex relationship between the dissolution performance, the drug product properties, and the systems necessary to measure the quality attribute. The Dissolution Working Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) has pooled our collective knowledge to outline some common ways that dissolution methods can fail. Examples and case studies are given to highlight errors related to equipment, method, materials, measurement, people, and the environment. Best practices for building method understanding and avoiding the exemplified issues are discussed. Case studies highlight the importance of buffer preparation, potential impact of contamination of the dissolution medium, additive-induced degradation, risks in the use of automation, differences between dissolution systems, and the effect of filter selection. Investing in analyst training programs, understanding the capabilities of your equipment portfolio, and using well-designed studies for robustness and ruggedness will reduce dissolution method investigations and improve compliance and productivity during the method lifecycle.

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“…A typical final step in sample preparation involves filtering the extracts prior to instrumental analysis [4][5][6][7][8], commonly by ultrahigh-performance liquid chromatography (UHPLC) or gas chromatography (GC) coupled to mass spectrometry (MS). Removal of particles is particularly important for UHPLC-MS/MS to prevent clogging of tubing and/or the column.…”

Section: Introductionmentioning

confidence: 99%

“…Analyte retention during filtration reduces the accuracy of results, especially if the calibration standards are not filtered in the same way as the final extracts. The main cause of analyte binding to membrane surfaces is weak secondary interactions such as electrostatic interactions (dipole-dipole, dipole-induced dipole, and ionic interactions), hydrogen bonding, hydrophobic interactions, and van der Waals forces [6,12,23]. The extent of the interactions depends on the chemical structure, ionization state, and physical properties of both the target compounds and the membrane material.…”

Section: Introductionmentioning

confidence: 99%

Comparison of filter membranes in the analysis of 183 veterinary and other drugs by liquid chromatography‐tandem mass spectrometry

Michlig,

Lehotay,

Lightfield

2024

J of Separation Science

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Although filtration is one of the most common steps in sample preparation for chemical analysis, filter membrane materials can leach contaminants and/or retain some analytes in the filtered solutions. In multiclass, multiresidue analysis of veterinary drugs, it is challenging to find one type of filter membrane that does not retain at least some of the analytes before injection in ultrahigh‐performance liquid chromatography‐tandem mass spectrometry (UHPLC‐MS/MS). In this study, different filter membranes were tested for use in UHPLC‐MS/MS analysis of 183 diverse drugs in bovine muscle, kidney, and liver tissues. Membranes evaluated consisted of polytetrafluoroethylene (PTFE), polyvinylidene difluoride (PVDF), polyethersulfone, nylon, and regenerated cellulose. Drug classes represented among the analytes included β‐agonists, β‐lactams, anthelmintics, macrolides, tetracyclines, sulfonamides, tranquilizers, (fluoro)quinolones, anti‐inflammatories, nitroimidazoles, coccidiostats, phenicols, and others. Although the presence of a matrix helped reduce the binding of analytes on surface active sites, all of the filter types partially retained at least some of the drugs in the final extracts. In testing by flow‐injection analysis, all of the membrane filters were also observed to leach interfering components. Ultimately, filtration was avoided altogether in the final sample preparation approach known as the quick, easy, cheap, effective, rugged, safe, efficient, and robust (QuEChERSER) mega‐method, and ultracentrifugation was chosen as an alternative.

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Filters in Dissolution Testing: Evaluation and Selection

Cited by 7 publications

References 14 publications

Validation of a UV spectrophotometric method to quantify losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8

Validation of a UV spectrophotometric method to quantify losartan potassium in tablets from the dissolution test at pH 1.2, 4.5 and 6.8

Dissolution Method Troubleshooting: An Industry Perspective

Comparison of filter membranes in the analysis of 183 veterinary and other drugs by liquid chromatography‐tandem mass spectrometry

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