Development and validation of reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantification of Efavirenz in Efavirenz-Enfuvirtide co-loaded polymer-lipid hybrid nanoparticles

Surve, Dhanashree H.; Jindal, Anil

doi:10.1016/j.jpba.2019.07.013

Cited by 21 publications

(15 citation statements)

References 15 publications

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“…Plotting the peak areas vs. concentration gave a high correlation coefficient value of 0.995. However, the correlation coefficient is no longer sufficient for determining linearity, according to the literature [16][17][18]. It is suggested to evaluate the fit of the ordinary least squares linear regression by assessing the homoscedasticity of data and, in the case of heteroscedasticity search for other models, which better defined the correlation between the concentration and the response of the detector [18,19].…”

Section: Discussionmentioning

confidence: 99%

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

et al. 2019

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Background: The administration of total parenteral nutrition (TPN) is a common procedure in intensive care units, where the concomitant use of other intravenous medication is frequently needed. One of the particularly dangerous complications for neurosurgical patients is meningitis, for which high doses of ampicillin (AMP) are used. In such cases, the addition of AMP to TPN admixtures would be a desirable procedure. Thus, the AMP determination method in TPN admixture was developed and validated. Methods: An isocratic HPLC analysis was performed on a LiChrospher C18 end-capped column (250 mm, 4.6 mm, 5 µm) with a C18 pre-column (LiChrospher 100, 4 mm, 5 µm). The flow rate was 1.0 mL min−1 and the detection wavelength was 230 nm. System suitability parameters, such as capacity factor, numbers of the theoretical plate, asymmetry factor, as well as validation parameters, including method precision, accuracy, linearity, selectivity, and robustness, were set up. Results: The method was shown to be linear, precise, accurate, specific, and robust, and it can be used for the quantitative analysis of AMP in TPN admixtures. Conclusions: The degradation of AMP in the TPN admixtures occurred according to first order kinetics. The degradation rate was high and dependent on the composition of the mixture and the storage conditions (t0.5 varied from 142.44 h to 300.45 h).

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Section: Discussionmentioning

confidence: 99%

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

et al. 2019

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“…The limit of detection (LOD) and the limit of quantitation (LOQ) for each analyte ( 1 , A , B , C , and D ) were calculated based on the standard deviation of the response and the slope of the calibration curve, generated from six replicate analysis applying the formula 1 [ 23 ]:

where k is the factor related to the level of confidence ( k = 3.3 and 10 for LOD and LOQ respectively), SD Sa is the standard deviation of the intercept, and S b is the slope.…”

Section: Methodsmentioning

confidence: 99%

“…The limit of detection (LOD) and the limit of quantitation (LOQ) for each analyte (1, A, B, C, and D) were calculated based on the standard deviation of the response and the slope of the calibration curve, generated from six replicate analysis applying the formula 1 [23]:…”

Section: Limit Of Detection and Limit Of Quantificationmentioning

confidence: 99%

Quantification of one Prenylated Flavanone from Eysenhardtia platycarpa and four derivatives in Ex Vivo Human Skin Permeation Samples Applying a Validated HPLC Method

et al. 2020

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Prenylated flavanones are polyphenols that have diverse biological properties. The present paper focuses on a HPLC method validation for the quantification of prenylated flavanones (2S)-5,7-dihydroxy-6-(3-methyl-2-buten-1-yl)-2-phenyl-2,3-dihydro-4H-1Benzopyran-4-one 1 and derivatives (2S)-5,7-bis(acetyloxy)-6-(3-methyl-2-buten-1-yl)-2-phenyl-2,3-dihydro-4H-1-Benzopyran-4-one A; (2S)-5-hydroxy-7-methoxy-6-(3-methyl-2-buten-1-yl)-2-phenyl-2,3-dihydro-4H-1-Benzopyran-4-one B; (8S)-5-hydroxy-2,2-dimethyl-8-phenyl-3,4,7,8-tetrahydro-2H,6H-Benzo[1,2-b:5,4-bˈ]dipyran-6-one C; and (8S)-5-hydroxy-2,2-dimethyl-8-phenyl-7,8-dihydro-2H,6H-Benzo[1,2-b:5,4-bˈ]dipyran-6-one D applied in biopharmaceutic studies. The linear relationships are proven with significant correlation coefficients (R2 ˃ 0.999) in the range of 1.56 to 200 μg/mL with low limits of detection and quantification, on average of 0.4 μg/mL and 1.2 μg/mL, respectively. The validation method used in this work is highly accurate and precise, with values lower than 15%. The relative standard deviation values of repeatability of the instrumental system are demonstrated with less than 0.6% for all studied flavanones. Therefore, the applicability method of the quantification of the prenylated flavanones was established using the permeation of human skin in the Franz cell system. During the method previously described, there was no interference observed from human skin components in ex vivo permeation studies.

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“…The robustness of method was evaluated by deliberate variation in chromatographic conditions including analytical instrument, wavelength, pH, mobile phase composition, column oven temperature and flow rate [28]. The robustness of the developed technique was evaluated by altering mobile phase ratio and flow rate.…”

Section: Robustnessmentioning

confidence: 99%

Development and validation of reversed phase high performance liquid chromatography (RP-HPLC) for quantification of captopril in rabbit plasma

Rasool

Qureshi

Ranjha

et al. 2021

Acta Chromatographica

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Th accurate rapid, simple and selective reversed phase high performance liquid chromatography (RP-HPLC) has been established and validated for the determination of captopril (CAP). Chromatographic separation was accomplished using prepacked ODSI C18 column (250 mm × 4.6 mm with 5 μm particle size) in isocratic mode, with mobile phase consisting of water: acetonitrile (60:40 v/v), pH adjusted to 2.5 by using 85% orthophosphoric acid at a flow rate of 1 mL/min and UV detection was performed at 203 nm. RP-HPLC method used for the analysis of CAP in mobile phase and rabbit plasma was established and validated as per ICH-guidelines. It was carried out on a well-defined chromatographic peak of CAP was established with a retention time of 4.9 min and tailing factor of 1.871. The liquid–liquid extraction method was used for extraction of CAP from the plasma. Excellent linearity (R2 = 0.999) was shown over range 3.125–100 µg/mL with mean percentage recoveries ranges from 97 to 100.6%. Parameters of precision and accuracy of the developed method meet the established criteria. Intra and inter-day precision (% relative standard deviation) study was also performed which was less than 2% which indicate good reproducibility of the method. The limit of detection (LOD) and quantification for the CAP in plasma were 3.10 and 9.13 ng/mL respectively. The method was suitably validated and successfully applied to the determination of CAP in rabbit plasma samples.

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Development and validation of reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantification of Efavirenz in Efavirenz-Enfuvirtide co-loaded polymer-lipid hybrid nanoparticles

Cited by 21 publications

References 15 publications

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

Development, Validation, and Stability Assessment Application of RP-HPLC-DAD Method for Quantification of Ampicillin in Total Parenteral Nutrition Admixtures

Quantification of one Prenylated Flavanone from Eysenhardtia platycarpa and four derivatives in Ex Vivo Human Skin Permeation Samples Applying a Validated HPLC Method

Development and validation of reversed phase high performance liquid chromatography (RP-HPLC) for quantification of captopril in rabbit plasma

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