Development and validation of RP-HPLC method for the analysis of Cobicistat and related impurities in bulk and pharmaceutical dosage forms

Ganji, Shiny; Satyavati, D.

doi:10.5958/2231-5675.2015.00001.0

Cited by 10 publications

(2 citation statements)

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“…The %RSD of the AR value was 0.44%, which is less than 2% (Naik et al, 2018;Swamy et al, 2014;Swathi et al, 2017). The SST focuses on determining the performance (Ganji & Satyavati, 2015) and reproducibility of the chromatography system based on the analysis carried out according to the results of the development (Zuben et al, 2020). The %RSD of the AR value of 0.44% indicating that the level of accuracy in the SST test is acceptable.…”

Section: System Suitability Test (Sst)mentioning

confidence: 92%

Development of Analysis and Validation of Human Insulin-Containing Matrices Using Reverse Phase-Liquid Chromatography

Ambarsari

Suryadi²,

Yanuar³

2022

jppipa, pendidikan ipa, fisika, biologi, kimia

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Licensed drugs containing human insulin are used as a routine therapy to maintain blood glucose levels in patients with diabetes mellitus. Meanwhile, production and storage factors can reduce the potency of these drugs, and this is important for patients. Therefore, a fast and reliable analytical method is needed to ensure quality, as well as safety and effectiveness without being affected by the matrices content, such as m-cresol and glycerol. The study was developed with the high-performance liquid chromatography using a reverse-phase column ReliantÔ C-18 (4.6 x 150 mm, 5 mm), 40°C column temperature, 215 nm UV-Vis detector, 1 mL/min flow rate, and 20 mL injection volume, while, ethylparaben was used as an internal standard. Furthermore, the separation was conducted with solution A and B containing Na2SO4 pH 2.3 and Na2SO4 pH 2.3 in acetonitrile (55:45, v/v) in a ratio of 38:62, v/v, while validation was performed according to ICH guideline. The human insulin retention time was 5.04±0.009 minutes, with linearity of 9.74-146.03 mg/mL (r = 0.9997). Accuracy and precision were 100.71±1.11% and 0.64%, while LOD and LOQ were 0.193 mg/mL and 0.643 mg/mL respectively. Human insulin remained stable at 23°C for 48 hours as demonstrated by ANOVA, a0.05. Based on the results, this method has the potential to separate human insulin from A-21 desamido insulin as a degradant and matrices, as well as allowing for testing many products in a short time.

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Section: System Suitability Test (Sst)mentioning

confidence: 92%

Development of Analysis and Validation of Human Insulin-Containing Matrices Using Reverse Phase-Liquid Chromatography

Ambarsari

Suryadi²,

Yanuar³

2022

jppipa, pendidikan ipa, fisika, biologi, kimia

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“…During the preparation of drug substances, some of the critical starting materials, reagents, intermediates, solvents and by-products inevitably end up in the inished products as impurities in new commercial active pharmaceutical ingredients (APIs). Method for the analysis of penciclovir and its related impurity in bulk drug as well as, pharmaceutical dosage forms (Ganji and Satyavati, 2016) and spectroscopic method for determination of Penciclovir and Entecavir (Elzaher et al, 2016) are available in the literature. But no method suitable method was found for the quanti ication of genotoxic impurities present in penciclovir.…”

Section: Introductionmentioning

confidence: 99%

A Selective and Sensitive Method for Simultaneous Quantification of Genotoxic Impurities in Penciclovir drug substance and its dosage forms using UPLC-MS/MS

P.Y.G¹,

B²,

Reddy³

et al. 2020

ijrps

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A selective, rapid and sensitive method was developed for the determination of genotoxic impurities (2-Amino-6-chloro purine and Bromo compound) in Penciclovir drug substance using RPUPLC-MS/MS. The chromatographic separation was performed on Kromasil C8 column (150 mm x 4.6 mm, 5 μm) maintained at 45°C using 0.1%formic acids in water as buffer and acetonitrile through gradient programme. The flow rate was maintained at 0.5mL/min with an injection volume of 10 μL. For the quantification of genotoxic impurities, positive-electrospray ionisation (ESI) mode was selected. Penciclovir and its impurities were well separated within the shortest run time of 16min. The chromatographic method was developed, and the results of all validation parameters showed that the technique is well confined to the limits of ICH guidelines. The method has high sensitivity, and the limit of detection was found to be as low as 0.15 and 0.30 ppm for 2-Amino-6-chloro purine and Bromo compound. The recovery of 2-Amino-6-chloro purine and Bromo compound are found in the range of 80-120%. The linearity of peak area versus concentration was demonstrated in the range of LOQ - 150% level of impurities with a correlation coefficient of 0.9999. The method has proved too robust by introducing minuscule changes in the chromatographic parameters. The method was successfully validated and applied for Penciclovir drug substances and their dosage forms to determine the mentioned genotoxic impurities.

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Determination of Darunavir and Cobicistat Simultaneously Using Stability Indicating RP-HPLC Method

2016

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Development and validation of RP-HPLC method for the analysis of Cobicistat and related impurities in bulk and pharmaceutical dosage forms

Cited by 10 publications

References 0 publications

Development of Analysis and Validation of Human Insulin-Containing Matrices Using Reverse Phase-Liquid Chromatography

Development of Analysis and Validation of Human Insulin-Containing Matrices Using Reverse Phase-Liquid Chromatography

A Selective and Sensitive Method for Simultaneous Quantification of Genotoxic Impurities in Penciclovir drug substance and its dosage forms using UPLC-MS/MS

Determination of Darunavir and Cobicistat Simultaneously Using Stability Indicating RP-HPLC Method

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