Development and Validation of a Novel RP-HPLC Method for the Determination of Cetrimide and Chlorhexidine Gluconate in Antiseptic Solution

Vrachas, Andreas; Gkountanas, Kostas; Boutsikaris, Haris; Dotsikas, Yannis

doi:10.3390/analytica3010006

Cited by 10 publications

(5 citation statements)

References 14 publications

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“…For the evaluation of the significant effects, the graphical approach was implemented [ 19 , 20 , 21 ]. The normal and half-normal plot graphs, along with Pareto charts, were utilized for this purpose.…”

Section: Resultsmentioning

confidence: 99%

Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method

et al. 2022

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Compounded medicinal products containing bupropion hydrochloride (BUP·HCl) and naltrexone hydrochloride (NTX·HCl) are available as adjunct therapy for the management of weight in obese/overweight adults. The present work describes the development and validation of a novel RP-HPLC method for a simultaneous quantitation during the dissolution of both drugs from compounded bilayer composition tablets. The method involves a Nucleosil 100-3 C-18 column (4.6 × 150 mm) and a mobile phase of a 70%/30% v/v ACN/KH2PO4·H2O aqueous solution of a 5 mM concentration. The flow rate was set at 1.35 mL/min and the detection was conducted using UV spectrophotometry (λmax 214 nm). The method was validated according to the ICH guidelines and fulfilled the specifications for the specificity, linearity, accuracy, precision and stability for both the sample and standard solutions. Furthermore, the robustness of the method was evaluated by applying a fractional factorial experimental design and by utilizing both graphical and statistical approaches to identify the HPLC factors that should be strictly controlled during the analysis. The method proved to be suitable for the analysis of the dissolution samples and, consequently, the release of BUP·HCl and NTX·HCl from the formulations.

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Section: Resultsmentioning

confidence: 99%

Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method

et al. 2022

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“…The following responses were assessed during robustness testing: the retention times (tR), the areas and the tailing factors (Tf) for the two analytes. For the assessment of the significant effects, the graphical approach was implemented (46)(47)(48), and to this purpose normal / half-normal graphs and Pareto charts were used (Figure 3).…”

Section: Robustness Testingmentioning

confidence: 99%

A novel HPLC method for the simultaneous determination of empagliflozin and dapagliflozin: Development, validation, robustness testing and greenness assessment

Kladi,

Zerva,

Dotsikas

2024

Arhiv za farmaciju

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Empagliflozin (EMPA) and Dapagliflozin (DAPA) are mainly recommended for the treatment of type 2 diabetes mellitus and heart failure. Based on the principles of green analytical chemistry, a simple, rapid and robust HPLC method was developed for the determination of both analytes in bulk. An isocratic protocol was developed using a C18 column, with a mobile phase consisting of just 30% organic modifier (ACN), while the remaining 70% was HPLC water. The run was completed within 4 min, with a flow rate of 1.20 mL/min, while UV detection took place at 230 nm. The method was then validated according to the ICH Q2 (R1) guidelines, and all the parameters examined were within the specified limits. Furthermore, the robustness of the method was evaluated by employing a factorial experimental design. Finally, the environmental friendliness of the proposed method was assessed by using the Analytical GREEness (AGREE) metric tool. The proposed method can be used for analysis of EMPA and DAPA in bulk, with potential application to the relevant pharmaceuticals.

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“…Te method can be considered specifc when the intended analyte can be determined without any interference by other excipients in the tested sample [13]. Te method's specifcity was evaluated by the following:…”

Section: Specifcitymentioning

confidence: 99%

Quantitative Analysis of Favipiravir by HPLC: Development and Validation

Qurt,

Eshtayyeh,

Naseef

et al. 2023

International Journal of Analytical Chemistry

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Favipiravir is a broad-spectrum oral antiviral agent and has been approved for the treatment of COVID-19 infection cases. It inhibits a protein known as RNA polymerase, which transcribes and replicates the viral RNA genome, causing the spread of the infection. The current study aimed to develop and validate a new analytical method utilizing HPLC in accordance with international requirements (ICH and FDA). The chromatographic conditions used to achieve good resolution and reproducibility were a mixture of acetonitrile and 0.1% phosphoric acid buffer in the ratio of 60 : 40 v/v as the mobile phase. The flow rate was 1.0 mL/min, the wavelength (λ) was determined at 250 nm, and a retention time was approximately 3 minutes for favipiravir. The HPLC analysis was performed on the Dionex 300 system equipped with a Phenomenex C8 (250 cm 4.6 mm) 5 μm column. The total runtime was 6.0 min. The findings indicated that the method had been validated satisfactorily. Across the concentration range of 0.10–0.75 mg/ml, the calibration curve revealed a linear relationship. The accuracy of the current method was to be 99.2%. The limit of detection (LOD) and limit of quantification (LOQ) were 0.004 and 0.013 ppm, respectively. The standard and sample solution repeatability tests revealed that the procedure was precise and within acceptable ranges. The RSD% for the determination of precision was <2%. The results for robustness and solution stability were within acceptable limits. Finally, the new method provided an excellent result for all analytical method validation parameters and met the acceptance criteria. In addition, the new approach has a short run time and a retention time of around 4 minutes.

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Development and Validation of a Novel RP-HPLC Method for the Determination of Cetrimide and Chlorhexidine Gluconate in Antiseptic Solution

Cited by 10 publications

References 14 publications

Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method

Dissolution Assay of Bupropion/Naltrexone Hydrochloride Salts of Bilayer Composition Tablets Following the Development and Validation of a Novel HPLC Method

A novel HPLC method for the simultaneous determination of empagliflozin and dapagliflozin: Development, validation, robustness testing and greenness assessment

Quantitative Analysis of Favipiravir by HPLC: Development and Validation

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