A simple and sensitive HPTLC method for quantitative analysis of darunavir ethanolate tablets

Patel, Bhavini N.; Suhagia, Bhanubhai N.; Patel, Chaganbhai N.; Panchal, Hiral J.

doi:10.1556/jpc.24.2011.3.11

Cited by 16 publications

(7 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A quantitative high performance thin layer chromatography (HPTLC) method for determination of darunavir was developed and validated by Patel and coworkers [7] and by Ramesh and coworkers [8]. The first authors used the wavelength 267 nm to detect the drug [11] and the second authors used reflectance scanning at 262 nm and mass spectra, [M +Na] + , m/z 569.80, to detect the drug [12]. A spectrophotometry method had already been used to determine darunavir in tablets; it was developed by Reddy and Ramireddy [9].…”

Section: Fig 1 Chemical Structure Of Darunavirmentioning

confidence: 99%

Development and Validation of First Derivative Spectrophotometric Method for Quantification of Darunavir in Tablets

Corrêa¹,

Serra²,

Salgado³

2014

BJPR

View full text Add to dashboard Cite

Aims: Darunavir is widely used in HIV/AIDS therapy. It is a HIV protease inhibitor that has excellent efficacy against the virus. The aim of this study is to develop and validate an analytical method fast and free of interferences for determination of darunavir ethanolate as raw material and tablet dosage form. Methodology: As the formulation excipients show high interference in darunavir determination by a direct UV absorption measurement a derivative spectrophotometry was applied. A selective, easy and fast method was achieved employing simple and cheap instrumentation by using first-order derivative spectrophotometry. Results: The first-derivation of spectrum of the drug measured between 200 and 400 nm allowed identification of the analyte and showed absence of placebo interference. The assay was based on the absorbance at 276nm. The linear concentration range was established from 11 to 21 μg/mL. The intra-day and inter-day precision expressed as RSD was 0.06% and 3.75% respectively with mean recovery of 99.84%. Conclusion: The proposed analytical method is able to quantify darunavir as raw material and tablets and can be used routinely by any laboratory applying a spectrophotometer

show abstract

Section: Fig 1 Chemical Structure Of Darunavirmentioning

confidence: 99%

Development and Validation of First Derivative Spectrophotometric Method for Quantification of Darunavir in Tablets

Corrêa¹,

Serra²,

Salgado³

2014

BJPR

View full text Add to dashboard Cite

show abstract

“…Recent studies suggested that protease inhibitors like Darunavir, Ritonavir, Nelfinavir showed no evidence of antagonism when used with TMC114 7,8 . Literature survey reveals that there are reports describing the determination of Darunavir in Plasma using liquid chromatography coupled with Tandem Mass Spectroscopy 9 , few HPTLC method for determination of Darunavir in rat plasma and in tablet dosage form its application to pharmacokinetic studies 10,11 , infrared spectroscopy method for determination of Darunavir in tablets 12 , and few RP-HPLC and Spectrophotometric methods 13,14 . The focus of present study is to develop and validate a rapid, stable and economic High performance Liquid Chromatographic method for Quality Control of DRN in tablet dosage form.…”

Section: Darunavir Is Chemically (3r3as6ar)-hexahydrofuro[23-b]furmentioning

confidence: 99%

New Validated Rp-HPLC Method for the Estimation of Darunavir in Bulk and Its Dosage Form

Mastanamma¹,

Sirisha²,

G³

et al. 2014

Int. Res. J. Pharm.

View full text Add to dashboard Cite

Present study describes the development and subsequent validation of reverse phase high performance liquid chromatographic (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 C18 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 minutes; total run time was set to 8 minutes. The standard curves were linear over the concentration range of 5-50 µg / ml 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 %. The % 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 slightly varying the chromatographic conditions. Validation studies demonstrated that proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible.

show abstract

“…Liquid chromatography–tandem mass spectrometry (LC‐MS/MS) methods for simultaneous determination of darunavir and other anti‐HIV agents in biological fluids have been reported (Heine et al ., ; Gupta et al ., ; Fayet et al ., ; Nageswara Rao and Guru Prasad, ). Several HPTLC methods for estimation of DRV in biological fluids and pharmaceutical dosage forms have been reported (Ramesh et al ., ; Patel et al ., ). A few stereospecific methods, including capillary electrophoresis (Leonard et al ., ) and chiral HPLC (Nageswara Rao et al ., , ), have also been reported in the literature.…”

Section: Introductionmentioning

confidence: 97%

Dried blood spot analysis of (+) and (−) darunavir enantiomers on immobilized amylose tris‐(3, 5‐dimethylphenylcarbamate) LC and its application to pharmacokinetics

Ramisetti

Arnipalli

Nimmu

2015

Biomedical Chromatography

View full text Add to dashboard Cite

Dried blood spot analysis is an innovative novel blood sampling technique gaining interest in drug discovery and development processes owing to its inherent advantages over the conventional whole blood, plasma or serum sample collection. The present manuscript describes the development and validation of a highly sensitive and precise method of evaluation of pharmacokinetics of (+) and (-) darunavir enantiomers on rat dried blood spots. The enantiomers on rat dried blood spots were extracted into methanol and separated by LC on a Chiralpak IA column using hexane and ethanol containing 0.1% DEA (75:25, v/v) as a mobile phase at 20°C; both the enantiomers were detected at 266 nm using a photodiode array detector. The method was validated in terms of selectivity, linearity, accuracy, precision and stability as per the US Food and Drug and Administration guidelines. The hematocrit effect on extraction recovery was evaluated and the mean recoveries of (-) and (+) enantiomers of darunavir from dried blood spots were found to be 85.76 and 88.91% respectively. The intra- and inter-day precision and accuracy were 3.1-8.4 and 0.8-4.8% respectively. The developed method was successfully applied to a pharmacokinetic study of (+) and (-) enantiomers of darunavir on rat dried blood spots.

show abstract

A simple and sensitive HPTLC method for quantitative analysis of darunavir ethanolate tablets

Cited by 16 publications

References 13 publications

Development and Validation of First Derivative Spectrophotometric Method for Quantification of Darunavir in Tablets

Development and Validation of First Derivative Spectrophotometric Method for Quantification of Darunavir in Tablets

New Validated Rp-HPLC Method for the Estimation of Darunavir in Bulk and Its Dosage Form

Dried blood spot analysis of (+) and (−) darunavir enantiomers on immobilized amylose tris‐(3, 5‐dimethylphenylcarbamate) LC and its application to pharmacokinetics

Contact Info

Product

Resources

About