Development and Validation of a RP-HPLC Method for the Determination of Zidovudine and Its Related Substances in Sustained-release Tablets

Santos, Jucimary V. dos; Carvalho, Luís A. E. Batista de; Pina, M. E.

doi:10.2116/analsci.27.283

Cited by 12 publications

(10 citation statements)

References 17 publications

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“…The peak area ratio (PAR) of EGCG/caffeine was plotted versus EGCG concentration. Linearity was assessed by computing the best fitting line equation and the coefficient of determination (r 2 ) between the nominal concentrations added and the measured PARs by linear regression data analysis [31][32][33].…”

Section: Linearitymentioning

confidence: 99%

Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations

et al. 2018

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(-)-Epigallocatechin gallate (EGCG) is a catechin found in green tea that has potential health benefits, such as anti-oxidant, anti-carcinogenic and anti-inflammatory effects. A rapid and sensitive Ultra-Performance Liquid Chromatographic (UPLC) method was developed and validated for the estimation of (-)-epigallocatechin-3-gallate in lipid-based formulation. The UPLC method was conducted on C18 analytical column (50 mm × 2.1 mm, 1.8 μm particle size). The mobile phase consisted of a mixture of acetic acid (1%, v:v; pH = 3), acetonitrile and water at volume ratio of 13:15:72 delivered at a flow rate of 0.5 mL/min. The diode array detector (DAD) acquisition wavelength was set at wavelengths 210 and 280 nm. Caffeine was used as internal standard. The tested validation parameters, i.e., selectivity, linearity, accuracy, precision, and sensitivity (Limit of detection and limit of quantification) were determined at both wavelengths. Results revealed that caffeine and EGCG peaks were eluted at retention times of 0.55 and 0.85 minutes, respectively. The calibration curve was linear over the concentration range of 10-60 μg/mL, with coefficients of determination (r2) of 0.9993 and 0.9998 nm at 210 and 280 nm, respectively. All the validation parameters were found within the acceptable range. The proposed method was successfully applied for the quantitation of EGCG in lipid-based formulation and statistical analysis with a reported method showed no significant difference at p < 0.05. Therefore, the proposed analytical method for EGCG can be considered as a rapid, selective and accurate analytical method that can be used for the quantitative analysis of EGCG.

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Section: Linearitymentioning

confidence: 99%

Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations

et al. 2018

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“…The developed and validated method was applied to analyses of the drug substances in their pharmaceutical preparations. The results were compared statistically by Student's -test and -test with the results obtained by the HPLC methods described in the literature [6,7]. The calculated -and -values did not exceed the tabulated values, indicating that there is no significant difference between the developed method and valid HPLC methods in the respect of mean values and standard deviations at 95% confidence level.…”

Section: Analysis Pharmaceutical Preparationsmentioning

confidence: 91%

“…The literature reveals various methods for the determination of the mentioned drug substances in biological fluids and pharmaceutical preparations such as UV-visible spectrophotometry [3][4][5], high performance liquid chromatography (HPLC) [6][7][8][9][10][11][12], capillary zone electrophoresis [13] for LVD, UV-visible spectrophotometry [14,15], HPLC [16][17][18], and high performance thin layer chromatography (HPTLC) [19,20] for ZVD.…”

Section: Introductionmentioning

confidence: 99%

Extractive Spectrophotometric Method for the Determination of Lamivudine and Zidovudine in Pharmaceutical Preparations Using Bromocresol Purple

Tekkeli

2013

Journal of Chemistry

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A new spectrophotometric method has been established for the quantitation of lamivudine (LVD) and zidovudine (ZVD) in pharmaceutical preparations. The method is based on the reaction between the investigated drug substances and bromocresol purple (BCP) producing ion-pair complexes in acidic buffers which are suitable for chloroform extraction. The maximum absorbance of these complexes was measured at 424 nm in chloroform. All variables were studied to optimize the reaction conditions. Linearity ranges were found to be 25–250 μg mL−1for LVD-BCP and 50–300 μg mL−1for ZVD-BCP. The developed method was successfully applied for the determination of these drugs in pharmaceutical preparations. Excipients in pharmaceutical formulations did not interfere in the analysis. The results were compared statistically with those obtained by the HPLC method reported in the literature. According to the results, the proposed method can be recommended for quality control and routine analysis.

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“…At suitable intervals, 5 mL samples were withdrawn and immediately replaced with equal volumes of the respective dissolution medium (maintained at 37 ± 2.0°C). The samples were filtered (45 µm), diluted, and spectrophotometrically analyzed for the AZT content, at λ = 266 nm, according to the validation procedure previously described 43 . The drug release profiles were represented through plots of the cumulative percentage of drug release (calculated from the total amount of AZT contained in each matrix) versus time.…”

Section: In Vitro Release Studiesmentioning

confidence: 99%

New sustained release of Zidovudine Matrix tablets − cytotoxicity toward Caco-2 cells

Santos¹,

Pina²,

Marques³

et al. 2012

Drug Development and Industrial Pharmacy

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Objective: The aim of this study was to adjust the zidovudine (AZT) release from solid tablets to an ideal profile, by developing matrices comprising swellable polymers with nonswellable ones.Methods: Directly compressed matrices comprised different ratios of hydroxypropylmethylcellulose K15M and K100M, ethylcellulose, and methacrylic acid (Eudragit® RS PO and Eudragit® RL PO) were prepared. Technological characterization and evaluation of the in vitro release behavior were carried out. Cell density and viability following drug exposure were evaluated by the SRB method, for the Caco-2 line, while cell morphology was assessed upon Trypan blue staining.Results: A specific formulation containing 5% of each excipient − HPMC K15M, HPMC K100M, Eudragit® RS PO, and Eudragit® RL PO − was found to yield the best release profile. Application of the Korsmeyer-Peppas model to the dissolution profile evidenced that a non-Fickian (anomalous) transport is involved in the drug release. Regarding the influence of the tablets' composition on the drug's cytotoxic effect toward the Caco-2 cell line, a reduction of cell biomass (0-15%) was verified for the distinct AZT formulations tested, F19 having displayed the highest cytotoxicity, after 24 and 48 h of incubation. Additionally, a high reversibility of the AZT effect was observed. Conclusions:The results showed that the simultaneous application of both hydrophilic and hydrophobic polymers can modulate the drug release process, leading to an improved efficacy and patient compliance. All AZT formulations studied were found to be cytotoxic against Caco-2 cells, F19 being the most effective one.

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Development and Validation of a RP-HPLC Method for the Determination of Zidovudine and Its Related Substances in Sustained-release Tablets

Cited by 12 publications

References 17 publications

Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations

Development and validation of a simple and rapid UPLC method for the in-vitro estimation of (-)-epigallocatechin-3-gallate in lipid-based formulations

Extractive Spectrophotometric Method for the Determination of Lamivudine and Zidovudine in Pharmaceutical Preparations Using Bromocresol Purple

New sustained release of Zidovudine Matrix tablets − cytotoxicity toward Caco-2 cells

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