| Autor: |
Suchitra, Duddagi, Kumar, Konda Shravan, Bhargavi, Chalavadi Sudha, Spandana, Racha, Krishna, Puli Ramya, Boggula, Narender |
| Předmět: |
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| Zdroj: |
Biochemical & Cellular Archives; Oct2024, Vol. 24 Issue 2, p2381-2389, 9p |
| Abstrakt: |
A new, simple, precise, rapid, selective and stability indicating Reversed-Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the simultaneous quantification of darunavir and cobicistat in API and its pharmaceutical dosage form. The method is based on Phenomenex Gemini C18 (4.6 × 250mm) 5µ column. The separation is achieved using isocratic elution by methanol: TEA buffer in the ratio of 65:35 v/v, pumped at flow rate 1.0mL/min and UV detection at 230 nm. The column is maintained at 40°C throughout the analysis. The total run time is about 6 min. The method is validated for specificity, accuracy, precision and linearity, robustness and ruggedness, system suitability, limit of detection and limit of quantitation as per International Conference of Harmonization (ICH) guidelines. The method is accurate and linear for quantification of darunavir, cobicistat between 10-50 µg/ml and 20-100 µg/ml, respectively. Further, satisfactory results are also established in terms of mean percent-age recovery (100.37% for darunavir and 100.34% for cobicistat, intra-day and inter-day precision (<2%) and robustness. The advantages of this method are good resolution with sharper peaks and sufficient precision. The results indicate that the method is suitable for the routine quality control testing of marketed tablet formulations. The method developed was simple and economical that can be adopted in regular quality control test in industries. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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