Chemometrics supported optimization of a multi-attribute monitoring liquid chromatographic method for estimation of palbociclib in its dosage form: Application to a new regulatory paradigm

Panda, Sagar Suman; Bera, Ravi Kumar Venkata Varaha; Sahu, Biswajit

doi:10.1016/j.pharma.2020.08.006

Cited by 4 publications

(3 citation statements)

References 14 publications

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“…Few methods have been reported for the determination of PLB in pharmaceutical dosage forms and biological samples, mainly using UPLC, 5 HPLC, 6,7 and LC-MS/MS 8,9 methods. As far as we know, no spectrofluorimetric methods have yet been adopted for its determination.…”

Section: Introductionmentioning

confidence: 99%

Rapid microwave-assisted synthesis of nitrogen-doped carbon quantum dots as fluorescent nanosensors for the spectrofluorimetric determination of palbociclib: application for cellular imaging and selective probing in living cancer cells

2023

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Section: Introductionmentioning

confidence: 99%

Rapid microwave-assisted synthesis of nitrogen-doped carbon quantum dots as fluorescent nanosensors for the spectrofluorimetric determination of palbociclib: application for cellular imaging and selective probing in living cancer cells

2023

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“…In addition, Al‐Shehri et al (2019) developed and validated an RP‐HPLC method for simultaneous analysis of PAL and letrozole. Kallepalli and Annapurna (2018) developed and validated an RP‐HPLC method for PAL, and Panda et al (2021) used Box–Behnken design for the optimization of the analytical method of PAL. The current research involved the development and validation of an easy, sensitive and cost‐effective, RP‐HPLC bioanalytical method for the assessment of PAL in rat plasma and matrices (kidney, liver, spleen, and heart) according to the guidelines of the International Council of Harmonization (ICH).…”

Section: Introductionmentioning

confidence: 99%

Design of experiment‐oriented development and validation of novel bioanalytical reverse phase high performance liquid chromatography method of palbociclib in rat plasma and tissues, and its application in pharmacokinetic studies

Rajana,

Pooja,

Bhavana

et al. 2023

Biomedical Chromatography

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The current research involved the development and validation of an easy, cost‐effective, and sensitive bioanalytical reverse‐phase high‐performance liquid chromatography method for the assessment of palbociclib (PAL) in rat plasma and kidney, liver, spleen and heart. A response surface methodology‐based Box–Behnken design was used to optimize critical chromatographic conditions such as buffer pH, organic phase concentration and flow rate to attain good sensitivity, tailing factor and retention time. The conditions were: pH of buffer, 4.5; organic phase concentration, 40%; Shimpac column with 1.0 ml/min flow rate. The responses were: tailing factor, 1.29 ± 0.03, sensitivity, 366,593 ± 8,592; and retention time, 4.5 ± 0.05 min. The samples were extracted by a protein precipitation method, and absolute recoveries were in the range of 88.99–95.08%. The linearity of the developed method was validated over the range 100–2,000 ng/ml (r2 ≥ 0.994) in all tested matrices. The developed bioanalytical method showed greater accuracy (0.98 and 4.01%) and precision (<4.88%). The method was optimized for the sensitive analysis of the PAL in rat plasma, and the kidney, liver, spleen and heart were effectively applied to pharmacokinetic studies.

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“…The molecular docking studies are useful for determining the binding capacity of drug molecules and their DPs towards the corresponding protein. Supported extensive literature search, LC-MS-MS [12][13][14][15][16][17][18][19] and LC techniques 20 were reported for therapeutic drug monitoring investigations in humans, animals and Pharmaceutical formulations. Hence, no method reported thus far for the characterization of Palbociclib together with DPs.…”

Section: Introductionmentioning

confidence: 99%

Method Development Combined with in silico Therapeutic and Toxicology Studies on Palbociclib and its Degradation Products to Assist in Discovery of New Molecule

Reehana

Sujana

2021

IJPI

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Background: Palbociclib is anti-cancer drug which interacts with cyclindependent kinase. There are no methods repoRTed for the characterization of palbociclib together with degradation products (DPs). The main aim of the study is to develop method combined with in silico therapeutic and toxicology studies on palbociclib and its DPs which assist in discovery of new molecule. Methods: A new analytical method was developed for the identification, characterization of palbociclib and DPs formed when subjected to forced degradation, using symmetry C 18 column, 150mm x 4.6mm, 3.5µm in isocratic mode with acetonitrile: formic acid (0.1%) (50:50). In silico toxicity for drugs and DPs were predicted using the Swiss ADME web tool and StarDrop Derek Nexus software for all DPs. Results: Validation: LOD and LOQ were 0.01 and 0.1 μg/ml. which shows accuracy data at three different concentrations of 50, 100, and 150 % in triplicate analysis. The % RSD for intra-day and intermediate precision was 0.47% and 0.33%, respectively, indicating the method was sufficiently precise. Mass spectrums (LC-MS/MS) of drug with m/z 447(RT= 4.075 min), DPI with [M+H] + at m/z 503(RT= 1.328 min), DPII with [M+H] + at m/z 540 (RT= 2.371 min), DPIII with m/z 46 (RT= 3.741 min) are reported. In docking studies, PS2 showed a higher docking score -12.289. Conclusion: The drug was found to degrade under forced degradation and DPs are characterized. All the DPs were found to be toxic except the major fragment ions (PS2), showed higher binding affinity than drug without toxicity. This is the lead molecule for further drug discovery.

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Chemometrics supported optimization of a multi-attribute monitoring liquid chromatographic method for estimation of palbociclib in its dosage form: Application to a new regulatory paradigm

Cited by 4 publications

References 14 publications

Rapid microwave-assisted synthesis of nitrogen-doped carbon quantum dots as fluorescent nanosensors for the spectrofluorimetric determination of palbociclib: application for cellular imaging and selective probing in living cancer cells

Rapid microwave-assisted synthesis of nitrogen-doped carbon quantum dots as fluorescent nanosensors for the spectrofluorimetric determination of palbociclib: application for cellular imaging and selective probing in living cancer cells

Design of experiment‐oriented development and validation of novel bioanalytical reverse phase high performance liquid chromatography method of palbociclib in rat plasma and tissues, and its application in pharmacokinetic studies

Method Development Combined with in silico Therapeutic and Toxicology Studies on Palbociclib and its Degradation Products to Assist in Discovery of New Molecule

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