Bioanalytical Method Development and Validation of Letrozole by LC-ESI-MS/MS in Human Plasma

Pal, Tapan Kumar

doi:10.15406/japlr.2017.04.00093

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…To deepen the knowledge about the interindividual variation in pharmacokinetics and relationship with patient outcome, large prospective clinical studies are needed, as well as more validated bioanalytical methods to support them. At the best of our knowledge, for the quantification of these drugs in human plasma, only one LC-UV method was published for PALBO [8], two LC-MS/MS methods were published for RIBO [9,10], while several LC-MS/MS assays [11][12][13][14][15][16] and one LC-UV method [17] were reported for LETRO. Recently, a LC-MS/ MS method was also proposed for the quantification of the CDKIs in human plasma [18] but not for the simultaneous determination of LETRO.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application

et al. 2020

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A novel LC-MS/MS method was developed for the quantification of the new cyclin dependent kinase inhibitors (CDKIs) palbociclib and ribociclib and the aromatase inhibitor letrozole used in combinatory regimen. The proposed method is appropriate to be applied in clinical practice due to the simple and fast sample preparation based on protein precipitation, the low amount of patient sample necessary for the analysis (10 μL) and the total run time of 6.5 min. It was fully validated according to FDA and EMA guidelines on bioanalytical method validation. The linearity was assessed (R 2 within 0.9992-0.9983) over the concentration ranges of 0.3-250 ng/mL for palbociclib, 10-10000 ng/mL for ribociclib and 0.5-500 ng/mL for letrozole that properly cover the therapeutic plasma concentrations. A specific strategy was implemented to reduce the carryover phenomenon, formerly known for these CDKIs. This method was applied to quantify the C min of palbociclib, ribociclib and letrozole in plasma samples from patients enrolled in a clinical study. The same set of study samples was analysed twice in separate runs to assess the reproducibility of the method by means of the incurred samples reanalysis. The results corroborated the reliability of the analyte concentrations obtained with the bioanalytical method, already proved by the validation process. The percentage differences were always within ±10% for all the analytes and the R 2 of the correlation graph between the two quantifications was equal to 0.9994. OPEN ACCESS Citation: Posocco B, Buzzo M, Poetto AS, Orleni M, Gagno S, Zanchetta M, et al. (2020) Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application. PLoS ONE 15(2): e0228822.

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Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application

et al. 2020

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“…This includes proper documentation, facility cleanliness, equipment calibration, and personnel training. Regular testing of raw elements and finished products is essential to verify their identity, purity, and potency [72]. Highperformance liquid chromatography (HPLC) or mass spectrometry (MS), are used to quantify active compounds and detect potential contaminants [73].…”

Section: Quality Control In Natural Product Manufacturingmentioning

confidence: 99%

Role of Natural Products in Inflammatory Pharmacology: Harnessing Nature's Potential Through Drug Delivery for Therapeutic Intervention

Bhowmik,

Shaharyar,

Sarkar

et al. 2023

jchr

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Inflammatory disorders encompass a broad spectrum of conditions marked by abnormal immune responses and persistent inflammation, affecting healthcare and patient wellbeing. Seeking alternative, safe, and efficacious treatments, researchers are turning to natural products within the realm of inflammatory pharmacology. These products, sourced from plants, animals, and microorganisms, hold promise as therapeutic interventions. Natural products exhibit complex interactions with molecular targets and signaling pathways involved in the inflammatory cascade across various diseases. These interactions result in anti-inflammatory (AI) effects and provide potential therapeutic benefits. These advantages may be harnessed via diverse drug delivery methods used for administering these natural products. Plant-derived compounds like CUR (CUR), found in turmeric, exhibit robust AI effects by modulating inflammation-associated pathways. Resveratrol (RES), present in grapes and berries, mitigates inflammation and oxidative stress. Similarly, animal-derived products such as omega-3 fatty acids (OFG) and bee venom components, along with microbial-derived substances like probiotics and fungal metabolites, display notable AI properties. It presents an all-encompassing perspective on the role of natural products in inflammatory pharmacology, scrutinizing their molecular mechanisms, efficacy, and applicability through drug delivery approaches in diverse inflammatory disorders. By synthesizing the latest scientific strides, the article deepens our comprehension of the therapeutic potential of natural products in managing inflammatory conditions through various drug delivery approaches, thereby offering valuable insights for future research and clinical utilization.

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“…About 60% of Letrozole gets bound to plasma protein mainly to albumin (55%). [11][12][13][14][15][16][17][18][19][20][21][22][23][24], UFLC [25], UPLC [26] in pharmaceutical formulations and biological samples (Table 3) [27][28][29][30][31], LC-MS/MS (Table 4) [32][33][34][35][36][37][38][39] and Capillary zone electrophoresis [40] for the quantification of Letrozole.…”

Section: Introductionmentioning

confidence: 99%

A Review on Different Analytical Methods: Letrozole

Prathyusha¹,

Sundararajan²

2020

Act Scie Pharma

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Letrozole is a third-generation aromatase inhibitor used for hormonal-sensitive breast cancer in postmenopausal women. Several analytical methods were developed to analyze Letrozole. The present review clearly covers all the analytical techniques used for the analysis of Letrozole available till date, which helps the researchers in developing new methods for estimation of Letrozole by considering the pros and cons of the previously developed methods. Figure 1: Structure of Letrozole. Letrozole (Figure 1) is chemically known as 4-[(4-cyanophenyl)-(1, 2, 4-triazol-1-yl) methyl] benzonitrile, with molecular formula C 17 H 11 N 5 and is freely soluble in dichloromethane; slightly soluble in ethanol; practically insoluble in water. It is a third-generation aromatase inhibitor used for hormonal-sensitive breast cancer in postmenopausal women. A very low daily dose of Letrozole is sufficient for unveiling antitumor activity and it is highly potent and selective and well tolerated [1]. Aromatase inhibitors can be classified based on their chemical structure as steroidal (type I inhibitors) and nonsteroidal (type II inhibitors), where anastrozole and Letrozole are nonsteroidal inhibitors and exemestane is a steroidal inhibitor [2]. Catalysis of enzyme aromatase was the final step in biosynthesis of estrogen so this step can be inhibited for inhibition of estrogen production [3].

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Bioanalytical Method Development and Validation of Letrozole by LC-ESI-MS/MS in Human Plasma

Cited by 5 publications

References 7 publications

Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application

Simultaneous quantification of palbociclib, ribociclib and letrozole in human plasma by a new LC-MS/MS method for clinical application

Role of Natural Products in Inflammatory Pharmacology: Harnessing Nature's Potential Through Drug Delivery for Therapeutic Intervention

A Review on Different Analytical Methods: Letrozole

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