Objective: This study points to build up and validate a simple methodology to quantify the most used drug sofosbuvir for the treatment of hepatitis C virus (HCV) infection, in human plasma by using atazanavir as an Internal Standard (IS) for preclinical studies and validate as per USFDA guidelines.Methods: Sofosbuvir was isolated from plasma samples by liquid-liquid extraction method using acetonitrile; good chromatographic separation was achieved on Kromasil Column (250 mm ×4.6 mm, 5 µm). The mobile phase consisted of 0.1 % orthophosphoric acid (OPA) buffer pH 2 and acetonitrile in the ratio of (68:32, v/v), respectively. The analysis time was 7 min at a flow rate 1 ml/min. The photodiode array detector (PDA) detection was carried out at 228 nm. The suggested method was validated by performing linearity, system suitability, specificity and sensitivity, accuracy and precision, recovery, ruggedness, stability studies. The method was validated as per USFDA guidelines.
Results:The developed method resulted in retention times of sofosbuvir and IS were found out to be 4.7 and 4.2 min respectively. The calibration curves are linear (r2 = 0.999) over the concentration range of 0.050-2.0 µg/ml of plasma analytes concentration. LOQ value was found to be 0.050 µg/ml with precision and accuracy. Within-batch % mean accuracy of the method ranged between 96.00% and 109.09%, and within-batch and total precision, expressed as the coefficient of variation, was 1.40-10.33%. Overall percentage mean recovery of sofosbuvir from spiked plasma was 84.14%. All the validated parameters were found to be within the limit.
Conclusion:A simple, accurate, precise, linear, rugged and rapid RP-HPLC method was developed for quantitative estimation of sofosbuvir in human plasma and should be suitable for conducting pharmacokinetics studies and therapeutic drug monitoring.
The major non-azadirachtin limonoids such as gedunin (1), epoxyazadiradione (3), nimbocinol (4), and nimolicinol (5) from Azadirachta indica A. Juss ('neem') and their derivatives were evaluated for their toxic action against fourth instar larvae of Aedes aegypti L. and Culex quinquefasciatus Say. Gedunin exhibited 100% toxic action against both the mosquito larvae at 50 and 10 ppm. Epoxyazadiradione and epoxynimolicinol also showed significant toxicities (> or =50%) against larvae of both mosquito species at 50 ppm. These neem limonoids can have benefits in mosquito-control programs.
Aims and Objectives:
The aim of this study is to study the efficacy of simvastatin in bone regeneration following the local application in third molar extraction sockets.
Materials and Methods:
This is a randomized controlled trial done on 50 patients involving 100 third molar teeth extraction sockets. The patients were randomly divided based on the placement of simvastatin. Extraction sockets which were treated with simvastatin were considered study sockets and without simvastatin were considered control sockets. The study socket was assigned for the placement of simvastatin (10 mg) powder along with gelfoam as carrier moistened with normal saline solution and control socket was assigned for the placement of gelfoam moistened with saline. Intraoral periapical radiographs were taken on the 1st, 4th, 8th, and 12th weeks, and mean gray scale values indicating bone density were evaluated for both the groups. Cone-beam computed tomography (CBCT) was taken by the end of the 12th week to further evaluate the osseous regeneration. Patients were compared and evaluated for bone density, pain, and swelling. Pain and swelling were evaluated on postoperative days 1 and 7.
Results:
The mean gray-level histogram values (bone density) were statistically highly significant in the study group compared to the control group in the 1st, 4th, 8th, and 12th weeks, and CBCT also showed statistically significant difference between the control and study group by the end of the 12th week.
Conclusion:
The present data suggest that the local application of simvastatin promotes and enhances bone formation in the extraction sockets, which provides a very cost-effective way for faster bone regeneration.
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