| Autor: |
G Alekhya, V Arun Babu, Sai Sirisha, Nagarjuna Nagar, SK Mastanamma, K Haritha |
| Rok vydání: |
2014 |
| Předmět: |
|
| Zdroj: |
International Research Journal of Pharmacy. 4:13-16 |
| ISSN: |
2230-8407 |
| DOI: |
10.7897/2230-8407.050103 |
| Popis: |
Present st udy describes the development and subsequent validation of reverse phase high perform ance liquid c hromatographic (RP - HPLC) method for estimation of Darunavir (Figure 1) a retroviral drug in bulk and its formulation with greater precision and accuracy. Separation was achieved on C 18 column (250 x 4.6 mm id.5 µm) in isocratic mode using water: methanol ( 0.2 % TEA) in the ratio of 30 : 70 (v / v) pH adjusted to 3 as mobile phase, pumped into column at flow rate 1.0 ml / min and the detection of eluent was carried out at 262 nm. Retention time was obtained at 5.2 min utes ; total run time was set to 8 min utes . The standard curves were linear over the concentration range of 5 - 50 µg / m l with correlation coefficient 0 .9995 and the LOD and LOQ values were 0.48 µg / ml and 1.5 µg / ml respectively. The percentage recovery was found to be within 98.2 % - 101.2 % . T he % RSD of intra - day and inter - day precision was found to be 0.69 and 1.3 for the assay concentration respectively. The percentage amount of marketed tablet formulation of Darunavir was found to be 99.66 %. The robustness of method has been studied by sli ghtly varying the chromatographic conditions. Validation studies demonstrated that proposed RP HPLC method is simple, specific, rapid, reliable and reproducible. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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