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Kallepalli, Pramadvara

doi:10.22377/ijgp.v12i01.1632

IJGP

2018

DOI: 10.22377/ijgp.v12i01.1632

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Pramadvara Kallepalli¹

Abstract: Introduction: A simple, sensitive stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of palbociclib. Palbociclib is an anticancer drug used for the treatment of breast cancer. It is a selective inhibitor of cyclin-dependent kinases. Materials and Methods: Waters Model 2695 alliance HPLC system (PDA Detector) with Inertsil ODS-3V (4.6 mm × 250 mm, 5 µm) was used for the chromatographic separation. Mobile phase consisting of ammonium acetate:acetonit… Show more

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Cited by 3 publications

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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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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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A Comprehensive Review of Analytical Techniques for Quantifying Cyclin‐dependent Kinase 4 and 6 Inhibitors in Biological Samples, Bulk, and Pharmaceutical Samples

Rathore,

Jenita,

2024

Separation Science Plus

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Cyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitors are utilized as a remedy for advanced hormone receptor‐positive, HER2‐negative breast cancer (BC). By targeting CDK4/6, these drugs inhibit the phosphorylation of the retinoblastoma protein during the early G1 phase, leading to cell cycle arrest, disruption of deoxyribonucleic acid replication, and effective suppression of cancer cell proliferation. Recently, there has been an increasing focus on the advancement of analytical techniques for the determination of CDK4/6 inhibitors. These analytical methods are essential in the enhancement and refinement of CDK4/6 inhibitors for the management of advanced BC. This review provides a comprehensive overview of the various analytical techniques used for the analysis of palbociclib, ribociclib, and abemaciclib, along with their metabolites in biological fluids (such as blood and urine samples), commercial products, Ringer's solution, and simultaneous estimation. High‐performance liquid chromatography and liquid chromatography‐mass spectrometry are the primary analytical techniques commonly employed for the analysis of CDK4/6 inhibitors. This analytical review also provides insights into pharmacokinetics and stability studies, as well as the use of analytical techniques in detecting impurities and determining the structure of degraded products.

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UV Spectrophotometric and UPLC assay methods for the determination of Palbociclib in bulk and Tablet Dosage Form

Bisoi,

Acharyya,

Kumar

2023

RJPT

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The goal of this study was to create a sensitive and reliable UV-spectrophotometric and reverse phase liquid chromatographic method for determining Palbociclib in bulk and pharmaceutical dosage forms. The current UV approach uses methanol and phosphate buffer as a solvent to evaluate absorption at a maximum wavelength of 220nm. Waters Acquity BEH C18 (2.1 x 50mm, 1.7µm) UPLC column with Empower 2 was used in the UPLC procedure. The mobile phase was made up of 50:50 (v/v) methanol and phosphate buffer.The drug obeyed Beer Lambert's law in the UV technique in the concentration range of 1-70µg/ml with a regression coefficient of 0.999. The linearity level in the UPLC technique was 1-100µg/ml. In the validation investigation, the developed UV and UPLC procedures were successful. For the UPLC and UV methods, the percentage purity of the marketed dosage form of Palbociclib was found to be 98.76 percent and 98.84 percent, respectively. The percent RSD of all validation parameters investigated, as suggested by the ICH recommendations, was determined to be less than 2 in both techniques. The two methods established for determining Palbociclib in bulk and tablet doses were found to be accurate, simple, and validated.

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Cited by 3 publications

References 2 publications

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

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

A Comprehensive Review of Analytical Techniques for Quantifying Cyclin‐dependent Kinase 4 and 6 Inhibitors in Biological Samples, Bulk, and Pharmaceutical Samples

UV Spectrophotometric and UPLC assay methods for the determination of Palbociclib in bulk and Tablet Dosage Form

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