Estimation and Validation of Residual Solvents in Marketed Formulation of Anti-Hypertensive Drug by Gas Chromatographic Method

Dubey, Pragati; Mittal, Neelam

doi:10.21276/irjps.2020.7.2.12

Cited by 1 publication

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“…Organic solvents are routinely applied during the synthesis of drug substances, excipients, or drug product formulation. They are not desirable in the final product, mainly because of their toxicity, influence on the quality of crystals of the drug substance, and their odour or taste, which can be unpleasant for patients [4]. To remove them, various manufacturing processes or techniques are in use.…”

Section: Fig 1: Structure Of Gliclazidementioning

confidence: 99%

Analytical Method Development and Validation for Estimation of Residual Solvents in Gliclazide Using Gas Chromatography

Madriwala

JAYS²

2022

Int J Curr Pharm Sci

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Objective: The present work discusses developing a novel method for estimation of residual solvents in Gliclazide using Gas chromatography and determining its consistency, reliability and reproducibility by performing its validation. Methods: A Gas chromatograph equipped with aflame ionization detector, column DB-624 (60 m x 0.32 mm x 1.8 µm) with Nitrogen as carrier gas was used and the column temperature was 40 °C (hold for 15 min) and increased to 240 °C at 20 °C per min. The solutions were prepared using-Methyl-2-Pyrrolidone (NMP) diluent as per the procedure given in protocol and appropriately injected as per the sequence. The validation parameters checked were System suitability, Specificity, Linearity and Range, Accuracy, Precision, Limit of detection, Limit of quantitation, Ruggedness and Robustness. Results: The data for each validation parameter tested is compiled and documented. It was found that the results obtained for each parameter compiled with their given acceptance criteria. Hence, the developed method was considered reproducible, reliable and consistent. Conclusion: The method of analysis complies with all the parameters tested and it was found to be reliable, consistent and reproducible.

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Section: Fig 1: Structure Of Gliclazidementioning

confidence: 99%