| Autor: |
Kumar, Praveen, Chaudhary, Meenu, Rathi, Vaibhav, Singh, Bhupendra, Vyas, Manish, Saini, Geetanjali |
| Předmět: |
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| Zdroj: |
AIP Conference Proceedings; 2023, Vol. 2800 Issue 1, p1-13, 13p |
| Abstrakt: |
Pharmaceutical analysis and need of drug Analysis pharmaceutical analysis is an important part of pharmaceutical chemistry which involves the science of extraction. Analytical research and development is a process that assures identity, safety, efficacy, purity, and quality control of a product. A simple precise, accurate and sensitive RP-HPLC method for determination of drug residues (Clonazepam) was developed and validated as per ICH guidelines, Clonazepam was eluted on EC (250mm X 4.6 mm); Nucleosil 100-5, C18 column. The mobile phase consisted of acetonitrile and water in the ratio (60:40) delivered at a flow rate of 1.0 ml/min. The retention time of Clonazepam was 5.5±0.2 minutes with a runtime of 10 minutes. The regression equations for clonazepam were found to be y=3E+06x – 397495. The calibration curves were found to be linear within the concentration range of 0.1-30 µg/ml for the drug with correlation coefficient R²=0.9999. The limits of detection, quantitation were established at 0.308 and 0.910 µg/ml for clonazepam. Texwipe Swabs were used to remove any residues of drugs from stainless steel surfaces and give the recoveries of 90.6% to 96%, method passed all the system suitability parameters having asymmetry factor of 1.1 and theoretical plates 15073, the method was found specific as no interference was observed due to diluent, placebo. The developed method was found rugged and robust over different parameters like benchtop stability of spiked plates, swab, variation in flow rate, column temperature. Therefore, it is suitable for the routine analysis of Clonazepam in pharmaceutical dosage forms from the surfaces of pharmaceutical manufacturing equipment and floor. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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