Method Development and Validation of Taurine and Acetyl Cysteine by Using RP-HPLC Method

Naik, Ranjitha; Kumar, Dileep; Meda, Venkatesh

doi:10.5958/2231-5659.2018.00038.3

Cited by 5 publications

(1 citation statement)

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“…The mean of retention times of human insulin, A-21 desamido insulin, and ethylparaben were 5.030.009 minutes, 6.100.008 minutes, and 12.690.003 minutes, respectively (Table 1). 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).…”

Section: System Suitability Test (Sst)mentioning

confidence: 99%

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: 99%

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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Effect of soft beverages on the in vitro dissolution of gastro-resistant tablets containing low dose Acetylsalicylic acid

Slavkova

Popova

Voycheva

et al. 2021

RJPT

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The need for additional fluids for easy absorption is typical for elderly patients and those with dysphagia. Most often, these patients take their medication with a glass of orange juice or another liquid instead of a glass of water. We conducted a dissolution test with gastro-resistant tablets acetylsalicylic acid where different kind of orange juice or soft drink wеre added to the release medium. As a control, release medium - buffers 1.2, 4.5 and 6.8 were used. The released aspirin was determined after HPLC analysis. The obtained data were fitted to different kinetic models. The results of the dissolution test in medium buffers with added different beverage showed results similar to those obtained in pure buffer, where it is used an artificial sweetener and different, when sugar or glucose-fructose syrup was used to sweeten the beverage. The most significant change was observed in the release kinetics of the active substance.To exclude the possibility that the other beverage ingredients or excipients used to make the tablets affect the release profile of acetylsalicylic acid, we conducted a beverage-like dissolution test. Instead of a original beverage, we used water and sugar syrup, in a concentration that is declared on the label of the original beverages. The results obtained confirm that different sugar concentrations alter the release profile of acetylsalicylic acid from gastro resistant tablets when they are taken with a glass of sugar-containing beverage instead of a glass of water.

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Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

Sharma¹,

Ankalgi²,

Devi³

et al. 2021

AJPA

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A rapid isocratic chromatographic procedure for the analysis of methotrexate, hydroxychloroquine sulfate in bulk drug and pharmaceutical formulations was developed validated in the present study. The mobile phase consists of a mixture of Water: Acetonitrile: Tetrahydrofuran in the proportion of 50:40:10 and pH maintained to 3with perchloric acid. Retention time was found to be 3.0 and 3.7minutes for methotrexate and hydroxychloroquine sulfate respectively. The method was performing by using the C18 column, ODS Hypersil column with UV detection at 318nm, and flow rate of 1.0ml/min. The percentage of recovery for both drugs was found to be 99.99%. All validation parameters were within limits as per the ICH guidelines.

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Method Development and Validation of Taurine and Acetyl Cysteine by Using RP-HPLC Method

Cited by 5 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

Effect of soft beverages on the in vitro dissolution of gastro-resistant tablets containing low dose Acetylsalicylic acid

Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

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