LC Determination of Ritonavir, a HIV Protease Inhibitor, in Soft Gelatin Capsules

Dias, Carolina Lupi; Rossi, Rochele Cassanta; Donato, Eliane Maria; Bergold, Ana María; Fröehlich, Pedro Eduardo

doi:10.1365/s10337-005-0670-0

“…From the literature survey, it was found that Ritonavir estimated by analytical methods such as reversed-phase high-performance liquid chromatographic (RP-HPLC) method 4,5,6,7,8,9,10 , LC-MS 11 and HPTLC method 12 . The developed method was simple, precise, specific and accurate.…”

Section: Fig 1: Chemical Structure Of Ritonavirmentioning

confidence: 99%

Untitled

2011

IJPSR

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A simple, precise, specific and accurate reverse phase HPLC method has been developed for the determination of Ritonavir in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on Symmetry C18 (4.6 x 100mm, 3.5 μm) column using a mixture of Buffer: Acetonitrile (50:50) as the mobile phase at a flow rate 1.0 ml/min. Linearity was observed in concentration range of 50-150μg/ml. The retention time of Ritonavir was 5.1 min. The analyte was monitored using UV detector at 239 nm. Results of analysis were validated statistically and by recovery studies. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

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“…It is official in Indian Pharmacopoeia 2 and United States Pharmacopoeia 3 . From the literature survey, it was found that Ritonavir estimated by analytical methods such as Reversed Phase High Performance Liquid Chromatographic (RP-HPLC) method 4,5,6,7,8,9,10 , LC-MS 11 and HPTLC method 12 . The developed method was simple, precise, specific and accurate.…”

Section: Fig 1: Chemical Structure Of Ritonavirmentioning

confidence: 99%

Untitled

2011

IJPSR

0

View full text Add to dashboard Cite

A simple, precise, specific and accurate reverse phase HPLC method has been developed for the determination of Ritonavir in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on Symmetry C18 (4.6 x 100mm, 3.5 μm) column using a mixture of Buffer: Acetonitrile (50:50) as the mobile phase at a flow rate 1.0 ml/min. Linearity was observed in concentration range of 50-150μg/ml. The retention time of Ritonavir was 5.1 min. The analyte was monitored using UV detector at 239 nm. Results of analysis were validated statistically and by recovery studies. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

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“…So far, two LC methods for stability indicating analysis were published for RTV soft gelatin capsules 43, 44. LC methods for the assay and purity control of RTV drug substance have been published in the IP,45 Ph.…”

Section: Ritonavirmentioning

confidence: 99%