研究目的
Development and validation of ultraviolet (UV) spectroscopic method for estimation of dexamethasone and betamethasone in a pharmaceutical dosage as per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
研究成果
The results obtained in this study demonstrate that the UV method described in the protocol is valid for the determination and assay of dexamethasone and betamethasone. Therefore, the method is suitable for its intended use. The present study describes a highly sensitive, accurate and reproducible UV method for determination of dexamethasone and betamethasone. This method involves simple, rapid, and inexpensive sample preparation method.
研究不足
The study does not mention any specific limitations.
1：Experimental Design and Method Selection:
The study involved the development and validation of a UV spectroscopic method for the estimation of dexamethasone and betamethasone. The method was validated for accuracy, precision, linearity, ruggedness, and robustness.
2：Sample Selection and Data Sources:
Betamethasone and dexamethasone were dissolved in 50 mL Methanol: water (1:2) and 50 mL distilled water, respectively.
3：List of Experimental Equipment and Materials:
UV-visible double beam spectrophotometer of Shimadzu with 1 cm stopper of quartz cells was used for the absorbance measurements. Analytical reagent grade methanol, betamethasone sodium phosphate, and dexamethasone of Sigma were used.
4：Experimental Procedures and Operational Workflow:
The method was validated for accuracy, precision, linearity, ruggedness, and robustness. The absorbance was measured at 241 nm.
5：Data Analysis Methods:
The method was validated according to ICH guidelines, including evaluation of linearity, limit of detection (LOD), limit of quantitation (LOQ), intraday and interday precision and accuracy, selectivity and specificity.
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