Stability-Indicating HPLC Method for the Determination of Darunavir Ethanolate

Reddy, B. Venkata; Jyothi, G.; Reddy, B. Sreekanth; Raman, N.V.V.S.S.; Reddy, K. Subhash; Rambabu, C.

doi:10.1093/chromsci/bms165

Cited by 26 publications

(10 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The literature survey revealed that few methods have been reported for the estimation of darunavir ethanolate in bulk and dosage forms. [11] The aim of the present study was to develop and validate a new simple, sensitive, and rapid reverse-phase high-performance liquid chromatography (RP-HPLC) method for the determination of darunavir ethanolate in bulk and pharmaceutical dosage form.…”

Section: Crasmentioning

confidence: 99%

Untitled

Kavitha¹

2020

AJP

View full text Add to dashboard Cite

Objective: Darunavir ethanolate is the last United States Food and Drug Administration approved protease inhibitor (PI). The drug is used along with other PIs (ritonavir/cobicistat) for the effective management of human immunodeficiency virus (HIV) HIV-1 infection. Darunavir ethanolate exerts its action by binding noncompetitively to HIV protease enzyme. The main objective of the present research work was to develop a new profound and novel reverse-phase high-performance liquid chromatography (RP-HPLC) for the estimation of darunavir ethanolate. Methods: As per the guidelines of the Food and Drug Administration and International Council for harmonization, the method was validated. The HPLC analysis was performed on the waters 2695 equipped with symmetry C 18 column 3.5 µm, 150 mm × 4.6 mm, with a mixture of acetonitrile:0.1% phosphate buffer (50:50 V/V) as the mobile phase, at the flow rate of 1 ml/min. The total run time was 5 min and the detection was performed at the wavelength (λ) of 262 nm. Results: The retention time for darunavir ethanolate was found to be 2.269 min. The standard curves were obtained with R 2 0.9997 and linear at the concentration range of 8-120 µg/ml. The limit of quantitation and limit of detection for darunavir ethanolate were found to be 0.08 µg/ml and 0.8 µg/ml, respectively. The method's accuracy was tested by percentage recovery tests and found to be 100.3%. The results obtained were within the accepted standards for linearity, accuracy, precision, specificity, and robustness. Conclusion: The proposed RP-HPLC method can be applied for the routine analytical estimation of darunavir ethanolate in bulk and tablet formulations.

show abstract

Section: Crasmentioning

confidence: 99%

Untitled

Kavitha¹

2020

AJP

View full text Add to dashboard Cite

show abstract

“…1d). A survey of chemical literature as shown that few articles are available for the determination of fesoterodine fumarate using LC and LC-MS [47][48][49], HPLC [50][51][52], UV [53][54][55] and electrophoresis [56]. An attempt has been made to develop a simple and rapid visible spectrophotometric method for the assay of selected drugs in tablet dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

El‐Didamony

Saad

Saleem

2018

Int J Pharm Pharm Sci

View full text Add to dashboard Cite

Objective: To develop and validate simple, rapid and sensitive spectrophotometric method for the assay of four antimuscarinic antagonists, namely oxybutynin (OXB), solifenacin (SOL), tolterodine (TOL) and fesoterodine (FES) in bulk and pharmaceutical formulations.Methods: The proposed method is based on the reaction of the selected drugs with eriochrome cyanine R (ECR) in buffered aqueous solution at pH 1.0. The formed ion-pair complexes were extracted with dichloromethane and measured quantitatively with maximum absorption at 464 nm. All variables that affect on color intensity such as pH, buffer volume and concentration of ECR and extractive solvents were studied and optimized.Results: The calibration graphs were linear over the concentration range of 4–24, 4–32, 4–32 and 2–22 mg/ml for OXB, SOL, TOL and FES, respectively. The stoichiometry of the reaction was found to be 1:1 in all cases. Molar absorptivity values were found to be 2.043×104, 1.856×104, 1.798×104 and 2.856×104 l/mol/cm for OXB, SOL, TOL and FES, respectively. Excipients which used as an additive in commercial formulations did not interfere in the analysis.Conclusion: The developed method was successfully applied to determine OXB, SOL, TOL and FES in pharmaceutical preparations. The developed method can be used for quality control and routine analysis where time, cost effectiveness and high specificity of analytical technique are of great importance.

show abstract

“…Darunavir is a protease inhibitor used in the treatment of Human Immunodeficiency Virus (HIV) infection. It is a pillar of therapy cocktail for patients with the virus [1] . Like most new drugs it presents low water solubility and poor bioavailability, leading to poor absorption in the gastrointestinal tract [2] .…”

Section: Introductionmentioning

confidence: 99%

Long-term stability study of complex darunavir:β-cyclodextrin

Kogawa¹

2016

JPP

View full text Add to dashboard Cite

Darunavir, a protease inhibitor most widely used in the treatment of HIV infection, was complexed with β-cyclodextrin due to the low solubility in water and its poor bioavailability. This research describes the study the long-term stability of the complex darunavir: β-cyclodextrin which was kept in a climatic chamber for 24 months at 30°C ± 2°C and 75 % UR ± 5 %. The samples were analysed using LC-MS, 250 mm × 4.6 mm CN Luna column, water + 0.1 % glacial acetic acid: acetonitrile + 0.1 % glacial acetic acid 60:40 (v/v) as mobile phase, flow rate of 1.0 mL min-1 , UV detection at 268 nm and ambient room temperature (25°C) before the start of study and thereafter 3, 6, 9, 12, 18 and 24 months. The data obtained associated with the infrared, TG, DSC and X-ray diffraction analysis was sufficient to study the behavior of complex darunavir: β-cyclodextrin. The results of this research indicate that the stability of the complex darunavir: β-cyclodextrin is high under conditions associated of temperature and humidity.

show abstract

Stability-Indicating HPLC Method for the Determination of Darunavir Ethanolate

Cited by 26 publications

References 15 publications

Untitled

Untitled

Extractive-Spectrophotometric Determination of Some Antimuscarinic Antagonist in Tablet Formulations Using Eriochrome Cyanine R

Long-term stability study of complex darunavir:β-cyclodextrin

Contact Info

Product

Resources

About