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Gupta A.,Kadi Sarva Vishwavidyalaya University | Gupta A.,Veeda Clinical Research | Singhal P.,Veeda Clinical Research | Shrivastav P.S.,Gujarat University | And 2 more authors.
Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences | Year: 2011

A simple, precise and rapid ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the quantification of darunavir, a protease inhibitor, using darunavir-d9 as internal standard (IS). The method involved liquid-liquid extraction of darunavir and IS in methyl- tert-butyl ether from 50. μL human plasma. The chromatographic separation was achieved on an Acquity UPLC BEH C18 (50 mm. ×. 2.1. mm, 1.7. μm particle size) analytical column under gradient conditions, in a run time of 1.6. min. The precursor. →. product ion transitions for darunavir (m/. z 548.1. →. 392.0) and IS (m/. z 557.1. →. 401.0) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring (MRM) and positive ion mode. The method was extensively validated for its selectivity, sensitivity, carryover check, linearity, precision and accuracy, reinjection reproducibility, recovery, matrix effect, ion suppression/enhancement, stability and dilution integrity. The linearity of the method was established in the concentration range of 1.0-5000 ng/mL. The mean relative recovery for darunavir (100.8%) and IS (89.8%) from spiked plasma samples was consistent and reproducible. The application of this method for routine measurement of plasma darunavir concentration was demonstrated by a bioequivalence study conducted in 40 healthy Indian subjects for a 600 mg tablet formulation along with 100 mg ritonavir as booster under fast and fed conditions. To demonstrate the reproducibility in the measurement of study data, an incurred sample reanalysis was done with 400 subject samples and the % change in concentration was within ±12%. © 2011 Elsevier B.V.

Varjani S.J.,Indian Institute of Science | Varjani S.J.,Kadi Sarva Vishwavidyalaya University | Upasani V.N.,Mg Science Institute
Bioresource Technology | Year: 2016

The aim of this work was to study the potential of an indigenous strain of Pseudomonas aeruginosa NCIM 5514, isolated from petroleum-polluted soil, for the biodegradation of crude petroleum oil. The isolate completely decolorized 2,6-dichlorophenol indophenol in 120 h when grown at (37 ± 1 °C), indicating its hydrocarbon utilizing nature. Ex situ biodegradation study was performed to find out quantitative utilization and biodegradation of paraffin(s) present in crude oil. When the culture was grown in Bushnell-Hass medium containing crude oil (3%, v/v) at 37 °C, 180 rpm for 60 days, the viscosity of the oil was reduced from 1883 cp to 1002 cp. Gravimetric and gas chromatographic analysis showed 61.03% and 60.63% of biodegradation of C8–C36+ hydrocarbons, respectively. These results indicated that the isolate has potential to be used for ex-situ and in-situ bioremediation of hydrocarbon pollutants and could have promising applications in petrochemical industry. © 2016 Elsevier Ltd

Shah B.,Kadi Sarva Vishwavidyalaya University | Deshpande S.,Kb Institute Of Pharmaceutical Education And Research
Value in Health Regional Issues | Year: 2014

Objective: To assess the influence of diabetes on health-related quality of life (HRQOL) in patients with coronary artery disease (CAD) and identify predictors of health status at 1-year follow-up after an acute coronary event. Methods: A prospective cohort study in patients diagnosed with CAD at a tertiary care hospital from India. The EuroQol five-dimensional (EQ-5D) questionnaire was administered at 1-year follow-up. Multivariate stepwise liner regression was used to assess predictors of EQ visual analogue scale (VAS) and EQ-5D questionnaire utility scores. Respondents reporting problems on the EQ-5D questionnaire were stratified by the presence of diabetes at baseline for comparison. Results: Of 960 (30% diabetic) patients with CAD enrolled in a main study cohort, 306 (76% males, 21% diabetic) responded to the HRQOL questionnaire at 1 year. Diabetic patients reported more difficulties/problems than did nondiabetic patients for EQ-5D questionnaire dimensions (mobility, 12.3% vs. 4.1%, P = 0.03; usual activities, 56.9% vs. 41.3%, P = 0.03; pain/discomfort, 50.8% vs. 17.8%, P < 0.001; anxiety/depression, 33.8% vs. 14.9%, P < 0.001), except for self-care (12.3% vs. 17.5%, P = 0.35). Mean ± SD EQ VAS and EQ-5D questionnaire utility scores were significantly lower for patients with CAD with diabetes versus those without diabetes (0.75 ± 0.15 vs. 0.83 ± 0.15, P = 0.0002, and 67.8 ± 8.8 vs. 73.6 ± 5.4, P = 0.0001, respectively). Presence of diabetes, use of beta-blockers on discharge, and treatment strategy significantly influenced the VAS score, whereas myocardial infarction as final diagnosis and the presence of prior CHF predicted worse EQ-5D questionnaire utility scores. Conclusions: The poorer HRQOL as assessed by the EQ-5D questionnaire among patients with CAD who had diabetes highlights the need of individualized treatment programs to improve outcomes in this most vulnerable population. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Parekh J.M.,Kadi Sarva Vishwavidyalaya University | Sanyal M.,St Xaviers College | Yadav M.,Cadila Pharmaceuticals Ltd | Shrivastav P.S.,Kadi Sarva Vishwavidyalaya University | Shrivastav P.S.,Gujarat University
Bioanalysis | Year: 2013

Background: Iloperidone is a novel antipsychotic drug with high affinity for serotonin and D2 dopamine receptors. A sensitive and rapid isotope dilution LC-MS/MS method has been developed for the simultaneous determination of iloperidone and its two major metabolites in human plasma. Results: The analytes and their deuterated analogs as internal standards were quantitatively extracted from 100-μl human plasma by SPE. The method was validated over the concentration range of 0.01-6 ng/ml for all the analytes. Baseline separation of analytes was possible within 3 min on ACE 5 C8 column. The accuracy and precision (%CV) of the method varied from 96.2 to 105%, and 1.17 to 4.75%, respectively. The extraction recovery was >84%, while the internal standard-normalized matrix factors ranged from 0.97-1.03 for all three analytes. Conclusion: The developed method was successfully applied to support a bioequivalence study in healthy volunteers. © 2013 Future Science Ltd.

Varjani S.J.,Indian Institute of Science | Varjani S.J.,Kadi Sarva Vishwavidyalaya University | Upasani V.N.,M G Science Institute
Bioresource Technology | Year: 2016

The present research work was undertaken with a mandate to study carbon spectrum utilization and structural characterization of biosurfactant produced by indigenous Pseudomonas aeruginosa NCIM 5514, which showed unique properties to utilize a large number of carbon sources effectively for production of biosurfactant, although glucose was the best carbon substrate. In Bushnell-Hass medium supplemented with glucose (1%, w/v), 3.178 ± 0.071 g/l biosurfactant was produced by this isolate in 96 h. The biosurfactant produced showed surface tension and emulsification activity values from 29.14 ± 0.05 to 62.29 ± 0.13 mN/m and 88.50 ± 1.96 to 15.40 ± 0.91%, respectively. Toluene showed highest emulsification activity followed by kerosene. However, kerosene exhibited emulsion stability for 30 days. Biosurfactant was characterized as a mixture of di-rhamnolipid (Rha-Rha-C10-C14:1) and mono-rhamnolipid (Rha-C8-C10) by FTIR, ESI-MS and LC–MS techniques. High biosurfactant yield opens up doors for the isolate to find utility in various industries. © 2016

Patel H.K.,Kadi Sarva Vishwavidyalaya University | Barot B.S.,Kadi Sarva Vishwavidyalaya University | Parejiya P.B.,Kadi Sarva Vishwavidyalaya University | Shelat P.K.,Kadi Sarva Vishwavidyalaya University | Shukla A.,Kadi Sarva Vishwavidyalaya University
Colloids and Surfaces B: Biointerfaces | Year: 2014

Vitiligo is a non contagious acquired pigmentation disorder with limited treatment possibilities. Clobetasol propionate (CP) is the drug-of-choice for vitiligo which suppresses the immune system by reducing immunoglobulin action and causes the restoration of melanocytes leading to repigmentation of skin. However, despite being effective, its low and variable bioavailability prompt for development of novel carrier that could effectively target CP to site of action without producing undesirable side-effects. Low solubility of CP in subsequent poor in vivo bioavailability was overcome by formulating microemulsion based gel of CP (MBC) which would enhance the percutaneous transport of CP into and across the skin barrier. Comprehensive characterization of MBC was carried out for viscosity, gel strength and rheological behavior. In vitro studies revealed much higher drug release, skin penetration and enhanced skin accumulation as compared to control (Cream of CP). In vitro and in vivo occlusion studies demonstrated similar occlusiveness for MBC and control. MBC exhibited 3.16 times higher stratum corneum CP levels compared to control. Visualization of cutaneous uptake in vivo using laser scanning microscopy confirmed targeting of CP to epidermis and dermis. Dermatopharmacokinetic studies of MBC showed enhanced drug deposition of CP in skin layers. MBC was assessed for in vivo efficacy by single blind randomized pilot clinical study. The efficacy was assessed by vitiligo area scoring index (VASI) method. After completion of trial, repigmentation of vitiligo patches in patients were evaluated and scored. MBC was superior in terms of faster repigmentation and efficacy when compared with control (p value. <. 0.5). Hence, it was concluded that CP loaded MBC possess enhanced skin localization as well as therapeutic activity in vitiligo patients. © 2014 Elsevier B.V..

Patel A.,Kadi Sarva Vishwavidyalaya University | Macwana C.,Kadi Sarva Vishwavidyalaya University | Parmar V.,Gujarat University | Patel S.,Gujarat University
Journal of AOAC International | Year: 2012

An accurate, simple, reproducible, and sensitive HPLC method was developed and validated for the simultaneous determination of atorvastatin calcium, ezetimibe, and fenofibrate in a tablet formulation. The analyses were performed on an RP C18 column, 150 × 4.60 mm id, 5 μm particle size. The mobile phase methanol-acetonitrile-water (76 + 13 + 11, v/v/v), was pumped at a constant flow rate of 1 mL/min. UV detection was performed at 253 nm. Retention times of atorvastatin calcium, ezetimibe, and fenofibrate were found to be 2.25, 3.68, and 6.41 min, respectively. The method was validated in terms of linearity, precision, accuracy, LOD, LOQ, and robustness. The response was linear in the range 2-10 μg/mL (r2 = 0.998) for atorvastatin calcium, 2-10 μg/mL (r2 = 0.998) for ezetimibe, and 40-120 μg/mL (r2 = 0.998) for fenofibrate. The developed method can be used for routine quality analysis of the drugs in the tablet formulation. © 2012 Publishing Technology.

Mishra T.,Kadi Sarva Vishwavidyalaya University | Shrivastav P.S.,Gujarat University
The Scientific World Journal | Year: 2014

Objectives. HIV protease inhibitors are used in the treatment of patients suffering from AIDS and they act at the final stage of viral replication by interfering with the HIV protease enzyme. The paper describes a selective, sensitive, and robust method for simultaneous determination of three protease inhibitors atazanavir, darunavir and ritonavir in human plasma by ultra performance liquid chromatography-tandem mass spectrometry. Materials and Methods. The sample pretreatment consisted of solid phase extraction of analytes and their deuterated analogs as internal standards from 50 μL human plasma. Chromatographic separation of analytes was performed on Waters Acquity UPLC C18 (50 × 2.1 mm, 1.7 μm) column under gradient conditions using 10 mM ammonium formate, pH 4.0, and acetonitrile as the mobile phase. Results. The method was established over a concentration range of 5.0-6000 ng/mL for atazanavir, 5.0-5000 ng/mL for darunavir and 1.0-500 ng/mL for ritonavir. Accuracy, precision, matrix effect, recovery, and stability of the analytes were evaluated as per US FDA guidelines. Conclusions. The efficiency of sample preparation, short analysis time, and high selectivity permit simultaneous estimation of these inhibitors. The validated method can be useful in determining plasma concentration of these protease inhibitors for therapeutic drug monitoring and in high throughput clinical studies. © 2014 Tulsidas Mishra and Pranav S. Shrivastav.

Awasthi A.K.,Wrocław University | Sylwester B.,Polish Academy of Sciences | Sylwester J.,Polish Academy of Sciences | Jain R.,Kadi Sarva Vishwavidyalaya University
Astrophysical Journal | Year: 2016

We investigate the evolution of the differential emission measure distribution (DEM[T]) in various phases of a B8.3 flare which occurred on 2009 July 04. We analyze the soft X-ray (SXR) emission in the 1.6-8.0 keV range, recorded collectively by the Solar Photometer in X-rays (SphinX; Polish) and the Solar X-ray Spectrometer (Indian) instruments. We conduct a comparative investigation of the best-fit DEM[T] distributions derived by employing various inversion schemes, namely, single Gaussian, power-law functions and a Withbroe-Sylwester (W-S) maximum likelihood algorithm. In addition, the SXR spectrum in three different energy bands, that is, 1.6-5.0 keV (low), 5.0-8.0 keV (high), and 1.6-8.0 keV (combined), is analyzed to determine the dependence of the best-fit DEM[T] distribution on the selection of the energy interval. The evolution of the DEM[T] distribution, derived using a W-S algorithm, reveals multi-thermal plasma during the rise to the maximum phase of the flare, and isothermal plasma in the post-maximum phase of the flare. The thermal energy content is estimated by considering the flare plasma to be (1) isothermal and (2) multi-thermal in nature. We find that the energy content during the flare, estimated using the multi-thermal approach, is in good agreement with that derived using the isothermal assumption, except during the flare maximum. Furthermore, the (multi-) thermal energy estimated while employing the low-energy band of the SXR spectrum results in higher values than that derived from the combined energy band. On the contrary, the analysis of the high-energy band of the SXR spectrum leads to lower thermal energy than that estimated from the combined energy band. © 2016. The American Astronomical Society. All rights reserved.

Patel H.K.,Kadi Sarva Vishwavidyalaya University | Barot B.S.,Kadi Sarva Vishwavidyalaya University | Parejiya P.B.,Kadi Sarva Vishwavidyalaya University | Shelat P.K.,Kadi Sarva Vishwavidyalaya University | Shukla A.,Kadi Sarva Vishwavidyalaya University
Colloids and Surfaces B: Biointerfaces | Year: 2013

The aim of the present investigation was to evaluate microemulsion as a vehicle for dermal drug delivery and to develop microemulsion based gel (MBC) of clobetasol propionate (CP) for the effective treatment of vitiligo. D-Optimal mixture experimental design was adopted to optimize the amount of oil (X1), Smix (mixture of surfactant and cosurfactant) (X2) and water (X3) in the microemulsion. The formulations were assessed for globule size (nm) (Y1) and solubility of CP in microemulsion (mg/ml) (Y2). The microemulsion containing 3% oil, 45% Smix and 50% water was selected as the optimized batch (ME). The globule size and solubility of CP in ME were 18.26nm and 36.42mg/ml respectively. Transmission electron microscopy showed that ME globules were spherical in shape. Carbopol 934P was used to convert microemulsion containing drug into gel form without affecting its structure. Ex-vivo permeation studies showed that cumulative amount of CP permeated (Qn) from ME, MBC and market formulation (MFCP) at 8h after application were 53.6±2.18, 28.43±0.67 and 37.73±0.77μgcm2 respectively. MBC showed greater retention of CP in to skin layers than ME and MFCP. Skin irritation studies showed MBC to be significantly less irritating than MFCP. Photomicrographs and scanning electron micrographs of skin sections treated with MBC showed significant changes in the skin structure, which was attributed to the interaction of microemulsion components with skin resulting in permeation enhancement and retention of CP into skin layers. It was concluded that CP loaded gel could be a promising formulation for effective treatment of vitiligo. © 2012 Elsevier B.V.

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