ABSTRACT

Analytical method validation is a process which has been demonstrated to provide a high degree of assurance that uniform batches will be produced a result that meet the required specifications. It is a process to confirm that the analytical procedure used for a specific test is suitable for intended use and help to improve identity, safety, quality, purity and potency of the drug substance. Cycloserine is an Antibiotic used to treat tuberculosis. The physiochemical characterization studies showed that Cycloserine is white to pale yellow crystalline powder, hygroscopic in nature and has melting point is 155 to 156 °C. Cycloserine is soluble in water, slightly soluble in methanol, propylene glycol .Develop a simple, precise and accurate UV Visible method for cycloserine drug. After considering the solubility water was selected as a solvent. Cycloserine showed maximum absorbance at 226.80 nm. In this method the linearity is observed between the range of 5-25 ?g/ml. Precision, Robustness, Ruggedness parameter were studied. Also Limit of Detection (LOD) and Limit of Quantitation (LOQ) were validated. The method or all parameter were validated with the help of ICH guideline. Keywords: Cycloserine, Spectrophotometric method, Validation
Publication date: 01/06/21

https://ijbpas.com/pdf/2021/June/MS_IJBPAS_2021_5544.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.6.5544