Development and Validation of an High-Performance Liquid Chromatography Method for the Determination of 17-Β Estradiol in Polymeric Nanoparticles

Koga, Adriana Yuriko; Lipinski, Leandro Cavalcante; Klein, Traudi; Farago, Paulo Vítor

doi:10.22159/ajpcr.2021.v14i5.41355

Cited by 5 publications

(4 citation statements)

References 20 publications

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“…Only a validated method should be employed for the estimation of drugs. The developed method was validated following the ICH Q2 (R1) guidelines and other literatures using the prescribed validation parameters [19][20][21][22][23][24][25][26][27][28][29][30].…”

Section: Methods Validationmentioning

confidence: 99%

A Validated Stability Indicating Rp-HPLC Method for Estimation of Avapritinib in Bulk and Tablet Dosage Form

Mishra¹,

SARKER²,

Ghosh³

et al. 2022

Int J App Pharm

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Objective: The present investigation aims to develop a simple, cost effective, and reliable stability-indicating RP-HPLC assay method for analysis of avapritinib in bulk and the tablet dosage form. Methods: The method was developed using Acetonitrile and Methanol in a ratio of 70:30 (v/v) as the mobile phase, flowing at a rate of 1 ml/min, in an isocratic mode. A reverse phase column (Symmetry C18 column, 250 mm x 4.6 mm, 5 µm) was used as the stationary phase. The detection of the compound was made using a UV detector set at 245 nm. The validation and force degradation studies of the method were done following the International Conference on Harmonization (ICH) guidelines. Results: The method was validated using the prescribed parameters like system suitability, LOD, LOQ, accuracy, precision, robustness, specificity etc. The relative standard deviation (% RSD) of the peak area observed in each case was found within the accepted range (< 2%). The tailing factor and the plate count were found to be less than 2 and more than 2000 respectively in each observation. The coefficient of correlation (r2) value in the linearity study was found to be 0.9997. The drug was found to be quantified accurately in presence of its degraded products. Conclusion: The developed simple and economic method is a suitable option for the qualitative and quantitative study of avapritinib in bulk and tablets even in presence of its degraded products which may arise because of oxidation, hydrolysis, thermal and photolytic decomposition.

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Section: Methods Validationmentioning

confidence: 99%

A Validated Stability Indicating Rp-HPLC Method for Estimation of Avapritinib in Bulk and Tablet Dosage Form

Mishra¹,

SARKER²,

Ghosh³

et al. 2022

Int J App Pharm

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“…The most substantial naturally-occurring human estrogen is 17 -estradiol (Figure 1) [1]. This β hormone, also known chemically as 1,3,5(10)estratrien-3,17-diol, is the most potent among endogenous estrogen steroids, including estrone and estriol.…”

Section: Introductionmentioning

confidence: 99%

Electrochemical Study of 17β-Estradiol and its Determination in Pharmaceutical Preparations using Square Wave Voltammetry

Yılmaz

Kadıoğlu

2023

Journal of the Turkish Chemical Society Section A: Chemistry

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In the present study, the electroanalytical behavior of 17β-estradiol was investigated using cyclic voltammetry. The procedure was based on 17β-estradiol being electrochemically oxidized at a platinum electrode in non-aqueous solutions. At 1.47 V, the oxidation peak was noted. It was discovered that 17β-estradiol's oxidation was diffusion-controlled. Additionally, a quick and easy square wave voltammetry method was developed and validated in this work to determine 17β-estradiol in pharmaceutical preparations. The calibration curve was linear at 5 and 30 µg/mL concentrations. The precision was given by relative standard deviation and was less than 3.36%. Accuracy was given with relative error and did not exceed 2.54%. In pharmaceutical preparations, 17β-estradiol had an average recovery of 100.3%. Under the chosen experimental conditions, no interference was found. The suggested method is highly accurate and precise. Therefore, the method applies to measuring 17β-estradiol in pharmaceutical formulations.

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“…These studies have demonstrated that HPLC is the most feasible and accurate technique for ensuring LIS quality in terms of mass and identifying structures. [8][9][10][11][12][13] A few techniques recorded for LIS in the published literature are spectrophotometry, [14][15][16] gas-liquid chromatography, 17 capillary electrophoresis, and polarography. 18,19 By creating and validating an HPLC method for the analysis of LIS in both bulk and gel formulation, our research intends to close this gap.…”

Section: Introductionmentioning

confidence: 99%

HPLC Method Validation for Quantification of Lisinopril

Pawar¹,

More²

2023

IJPQA

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This study aimed to develop a straightforward, sensitive, exact, quick, and accurate reverse phase high performance liquid chromatography (RP-HPLC) method for figuring out how much lisinopril is in pharmaceutical gels and other large amounts of medication. Agilent Zorbax Bonus-RP column (250 x 4.6 mm, 5μ) was used for the chromatographic separation. “A mobile phase composed of methanol and trifluoroacetic acid (50:50 v/v) was used to develop the analytical procedure. The flow was found to be occurring at a rate of 1-mL/min and with a wavelength of 215 nm. The retention time was 2.28 min. In a concentration range from 3–7 μg/mL (r2=0.998), the drug’s response was determined to be linear. The LoQ was 1.11 μg/mL, while the LoD was 0.36 μg/mL. Lisinopril’s %assay was determined to be 98.22%, while assays for the other medicines in the commercial formulation showed no interference from the excipients. This method functions well and can be applied to routine analysis.

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Development and Validation of an High-Performance Liquid Chromatography Method for the Determination of 17-Β Estradiol in Polymeric Nanoparticles

Cited by 5 publications

References 20 publications

A Validated Stability Indicating Rp-HPLC Method for Estimation of Avapritinib in Bulk and Tablet Dosage Form

A Validated Stability Indicating Rp-HPLC Method for Estimation of Avapritinib in Bulk and Tablet Dosage Form

Electrochemical Study of 17β-Estradiol and its Determination in Pharmaceutical Preparations using Square Wave Voltammetry

HPLC Method Validation for Quantification of Lisinopril

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