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Journal of Management Analytics 2024年第1期11卷 110-134页

作者： Supriya Tiwari Kunal Shah Kajal Bhimani Department of Science and Humanities Apollo Institute of Engineering&TechnologyGTUAhmedabadIndia Department of Mathematics SMMPISRKadi Sarva VishwavidyalayaGandhinagarIndia AVAerials 401 Swarnim Business Hub-1 New Chamunda SocietyGodrej Garden CityGotaAhmedabadIndia

The proposed study offers the first-of-its-kind economic production quantity model for deteriorating items having a demand rate to be price dependent under the effect of inflation and reliability with partial trade *** model is extended under an uncertain environment by assuming inventory parameters to be triangular fuzzy numbers and cloudy triangular fuzzy *** objective of the study is to maximize the profit of the inventory system and to identify the most suitable environment for the proposed *** are verified using the numerical ***,the comparative study is presented to justify the nature of fuzzy and cloudy fuzzy *** analysis under all environments is conducted to identify the most sensitive parameters of all.

关键词： EPQ partial trade credit inflation reliability triangular fuzzy number cloudy triangular fuzzy number

Physical properties of lunar craters

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Research in Astronomy and Astrophysics 2017年第3期17卷 23-38页

作者： Maitri P. Joshi Kushal R Bhatt Rajmal Jain Shri Maneklal M.Patel Institute of Sciences and Research Kadi Sarva VishwavidhyalayaGandhinagar-382015India

The surface of the Moon is highly cratered due to impacts of meteorites, asteroids, comets and other celestial objects. The origin, size, structure, age and composition vary among craters. We study a total of 339 craters observed by the Lunar Reconnaissance Orbiter Camera （LROC）. Out of these 339 craters, 214 craters are known （named craters included in the IAU Gazetteer of Planetary Nomenclature） and 125 craters are unknown （craters that are not named and objects that are absent in the IAU Gazetteer）. We employ images taken by LROC at the North and South Poles and near side of the Moon. We report for the first time the study of unknown craters, while we also review the study of known craters conducted earlier by previous researchers. Our study is focused on measurements of diameter, depth, latitude and longitude of each crater for both known and unknown craters. The diameter measurements are based on considering the Moon to be a spherical body. The LROC website also provides a plot which enables us to measure the depth and diameter. We found that out of 214 known craters, 161 craters follow a linear relationship between depth （d） and diameter （D）, but 53 craters do not follow this linear relationship. We study physical dimensions of these 53 craters and found that either the depth does not change significantly with diameter or the depths are extremely high relative to diameter （conical）. Similarly, out of 125 unknown craters, 78 craters follow the linear relationship between depth （d） and diameter （D） but 47 craters do not follow the linear relationship. We propose that the craters following the scaling law of depth and diameter, also popularly known as the linear relationship between d and D, are formed by the impact of meteorites having heavy metals with larger dimension, while those with larger diameter but less depth are formed by meteorites/celestial objects having low density material but larger diameter. The craters with very high depth and with very small d

关键词： Moon meteorites meteors meteoroids- planets and satellites: surfaces

Determination of mycophenolic acid in human plasma by ultra performance liquid chromatography tandem mass spectrometry

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Journal of Pharmaceutical Analysis 2014年第3期4卷 205-216页

作者： Vivek Upadhyay Vikas Trivedi Gaurang Shah Manish Yadav Pranav S.Shrivastav Chemistry Department Kadi Sarva VishwavidyalayaGandhinagar 382015India Department of Chemistry School of SciencesGujarat University

A simple, sensitive and high throughput ultra performance liquid chromatography tandem mass spectrometry method has been developed for the determination of mycophenolic acid in human plasma. The method involved simple protein precipitation of MPA along with its deuterated analog as an internal standard （IS） from 50 mL of human plasma. The chromatographic analysis was done on Acquity UPLC C18 （100mm×2.1mm,1.7μm） column under isocratic conditions using acetonitrile and 10 mM ammonium formate, pH 3.00 （75：25, v/v） as the mobile phase. A triple quadrupole mass spectrometer operating in the positive ionization mode was used for quantitation. In-source conversion of mycophenolic glucuronide metabolite to the parent drug was selectively controlled by suitable optimization of cone voltage, cone gas flow and desolvation temperature. The method was validated over a wide concentration range of 15-15000 ng/mL. The mean extraction recovery for the analyte and IS was 〉95%. Matrix effect expressed as matrix factors ranged from 0.97 to 1.02. The method was successfully applied to support a bioequivalence study of 500 mg mycophenolate mofetil tablet in 72 healthy subjects.

关键词： Mycophenolic acid Mycophenolic acid-d3 UPLC-MS/MS In-source conversion Incurred sample reanalysis

Application of UPLC-MS/MS for separation and quantification of 3α-Hydroxy Tibolone and comparative bioavailability of two Tibolone formulations in healthy volunteers

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Journal of Pharmaceutical Analysis 2013年第4期3卷 270-277页

作者： Vijay P.Shinde Ashutosh Pudage Arvind Jangidi Hiren Mistri P.K.Patel kadi sarva Vishvavidyalaya Sarva Vidyalaya Campus Accutest Research Laboratories (Ⅰ) Pvt.Ltd. Unit ⅡOpp.The Grand Bhagwati Hotel Department of Chemistry M.G.Science Institute

A novel, fast, sensitive and robust method based on ultra-performance liquid chromatography coupled to atmospheric pressure electrospray ionization tandem mass spectrometry （UPLC-ESI-MS/MS） has been developed to separate two Tibolone stereoisomers i.e., 3α-Hydroxy Tibolone and 3β-Hydroxy Tibolone and to quantify 3α-Hydroxy Tibolone using p-toulenesulfonyl isocyanate （PTSI） as a derivatizing reagent in human plasma. 3α-Hydroxy Tibolone-13CD3 was used as an internal standard （IS）. The analyte and IS were extracted from human plasma by liquid-liquid extraction using ethyl acetate. Extracted samples were analyzed by UPLC-ESI-MS/MS. Chromatography was performed using binary gradient on UPLC analytical column. A linear calibration curve over the range of 0.100-35.000 ng/ mL was obtained and lower limit of quantification （LLOQ） was 0.100 ng/mL demonstrating acceptable accuracy and precision. This method was successfully applied to a pharmacokinetic study in order to compare a test Tibolone 2.5 mg formulation vs. a reference 2.5 mg Tibolone tablet formulation in 50 post-menopausal/surgical menopause female human volunteers under fasting conditions. It is concluded that test formulation of Tibolone is bioequivalent to reference formulation of Tibolone.

关键词： UPLC Tibolone Pharmacokinetics p-toulenesulfonylisocyanate

Determination of ergocalciferol in human plasma after Diels-Alder derivatization by LC-MS/MS and its application to a bioequivalence study

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Journal of Pharmaceutical Analysis 2017年第6期7卷 417-422页

作者： Pritesh Contractor Abhishek Gandhi Gajendra Solanki Priyanka A. Shah Pranav S. Shrivastav Department of Chemistry Kadi Sarva Vishwavidyalaya Gandhinagar Ahmedabad-382015 India Bioanalytical Department Veeda Clinical Research Ahmedabad-387810 India Department of Chemistry School of Sciences Gujarat University Ahmedabad-380009 India

An accurate, sensitive and selective method is developed for determination of ergoealeiferol （vitamin D2） in human plasma using LC-MS/MS. After liquid-liquid extraction with n-hexane, ergoealeiferol was derivatized by reacting with 4-phenyl-l,2,4-triazoline-3,5-dione （PTAD）, a strong dienophile based on Diels-Alder reaction. Ergocalciferol and its deuterated internal standard, ergocalciferol-d6, were analyzed on X Select CSH Cls （100 mmx4.6 mm, 2.5 lam） column using acetonitrile and 0.1% （v/v） formic acid in water containing 0.14% methylamine within 6.0 min under gradient elution mode. Tandem mass spectrometry in positive ionization mode was used to quantify ergocalciferol by multiple reaction monitoring （MRM）. Entire data processing was done using Watson LIMSTM software which provided excellent data integrity and high throughput with improved operational efficiency. The major advantage of this method includes higher sensitivity （0.10 ng/mL）, superior extraction efficiency （〉83%） and small sample volume （100 ~tL） for processing. The method was linear in the concentration range of 0.10-100 ng/mL for ergoealciferol. The intra-batch and inter-batch accuracy and precision （% CV） values varied from 97.3% to 109.0% and 1.01% to 5.16%, respectively. The method was successfully applied to support a bioequivalence study of 1.25 mg ergoealciferol capsules in 12 healthy subjects.

关键词： Ergocalciferol Diels-Alder reaction 4-phenyl- 1 2 4-triazoline-3 5-dione LC-MS/MS Human plasma

Determination of asenapine in presence of its inactive metabolites in human plasma by LC-MS/MS

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Journal of Pharmaceutical Analysis 2018年第5期8卷 341-347页

作者： Nirav R Patel Mallika Sanyal Naveen Sharma Dinesh S.Patel Pranav S.Shrivastav Bhavin N.Patel Bioanalytical Laboratory Uiantha Research India Ltd.BodakdevAhmedabad 380054GujaratIndia kadi sarva viswavidyalaya Sector-15Ghandhinagar 382715GujaratIndia Department of Chemistry St.Xavier's CollegeNavrangpuraAhmedabad 380009GujaratIndia Department of Chemistry School of SciencesGujarat UniversityNavrangpuraAhmedabad 380009GujaratIndia

A highly selective and sensitive liquid chromatography-tandem mass spectrometry （LC-MS/MS） assay has been described for the determination of asenapine （ASE） in presence of its inactive metabolites N-desmethyl asenapine （DMA） and asenapine-N-glucuronide （ASG）. ASE, and ASE 13C-d3, used as internal standard （IS）, were extracted from 300 μL human plasma by a simple and precise liquid-liquid extraction procedure using methyl tert-butyl ether. Baseline separation of ASE from its inactive metabolites was achieved on Chromolith Performance RPse （100 mm ×4.6 mm） column using acetonitrile- 5.0 mM ammonium acetate-10% formic acid （90：10：0.1, v/v/v） within 4.5 min. Quantitation of ASE was done on a triple quadrupole mass spectrometer equipped with electrospray ionization in the positive mode. The protonated precursor to product ion transitions monitored for ASE and ASE 13C-d3 were m/z 286.1 → 166.0 and m/z 290.0 → 166.1, respectively. The limit of detection （LOD） and limit of quantitation （LOQ） of the method were 0.0025 ng/mL and 0.050 ng/mL respectively in a linear concentration range of 0.050-20.0 ng/mL for ASE. The intra-batch and inter-batch precision （% CV） and mean relative recovery across quality control levels were 〈 5.8% and 87.3%, respectively. Matrix effect, evaluated as IS-normalized matrix factor, ranged from 1.03 to 1.05. The stability of ASE under different storage conditions was ascertained in presence of the metabolites. The developed method is much simpler, matrix free, rapid and economical compared to the existing methods. The method was suc- cessfully used for a bioequivalence study of asenapine in healthy Indian subjects for the first time.

关键词： Asenapine Asenapine 13C-d3 Metabolites LC-MS/MS Bioequivalence study Human plasma

Highly sensitive LC–MS/MS method to estimate doxepin and its metabolite nordoxepin in human plasma for a bioequivalence study

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Journal of Pharmaceutical Analysis 2018年第6期8卷 378-385页

作者： Nirav P.Patel Mallika Sanyal Naveen Sharma Dinesh S.Patel Pranav S.Shrivastav Bhavin N.Patel Bio-Analytical Laboratory Cliantha Research India Ltd.BodakdevAhmedabad 380054GujaratIndia kadi sarva viswavidyalaya Sector-15Ghandhinagar 382715GujaratIndia Department of Chemistry St.Xavier's CollegeNavrangpuraAhmedabad 380009GujaratIndia Department of Chemistry School of SciencesGujarat UniversityNavrangpuraAhmedabad 380009GujaratIndia

A selective, sensitive and rugged liquid chromatography–tandem mass spectrometry(LC–MS/MS) assay has been developed for the simultaneous determination of doxepin(Dox) and its pharmacologically active metabolite, nordoxepin(NDox) in human plasma. The analytes and their internal standards(IS)were extracted from 500 m L of human plasma by liquid-liquid extraction using methyl tert-butyl *** separation was achieved on Hypurity C8 column(100 mm ? 4.6 mm, 5 mm) using a mixture of acetonitrile-methanol(95:5, v/v) and 2.0 mM ammonium formate in 93:7(v/v) ratio. Detection was accomplished by tandem mass spectrometry in the positive ionization and multiple reaction monitoring acquisition mode. The protonated precursor to product ion transitions studied for Dox, NDox,and their corresponding ISs, propranolol and desipramine, were m/z 280.1-107.0, 266.0-107.0,260.1-116.1 and 267.1-72.1, respectively. A linear dynamic range of 15.0–3900 pg/mL for Dox and 5.00–1300 pg/mL for NDox was established with mean correlation coefficient(r2) of 0.9991 and 0.9993, respectively. The extraction recovery ranged from 86.6%–90.4% and 88.0%–99.1% for Dox and NDox, respectively. The intra-batch and inter-batch precision(% CV) across quality control levels was r 8.3% for both the analytes. Stability evaluated under different storage conditions showed no evidence of degradation and the % change in stability samples compared to nominal concentration ranged from 4.7% to12.3%. The method was successfully applied to a bioequivalence study of 6 mg doxepin hydrochloride orally disintegrating tablet in 41 healthy Indian subjects under fasting and fed conditions.

关键词： Doxepin Nordoxepin LC–MS/MS Liquid-liquid extraction Human plasma Bioequivalence study

Liquid chromatography-tandem mass spectrometry method for simultaneous determination of albendazole and albendazole sulfoxide in human plasma for bioequivalence studies

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Journal of Pharmaceutical Analysis 2016年第4期6卷 226-234页

作者： Dhiraj M.Rathod Keyur R.Patel Hiren N.Mistri Arvind G.Jangid Pranav S.Shrivastav Mallika Sanyal Department of Chemistry Kadi Sarva Vishwavidyalaya Bioanalytical Research Department Accutest Research Lab Department of Chemistry School of SciencesGujarat University Department of Chemistry St.Xavier's College

An improved high performance liquid chromatography-tandem mass spectrometry（LC-MS/MS） method has been developed for sensitive and rapid determination of albendazole（ABZ） and its active metabolite,albendazole sulfoxide（ABZSO）,in the positive ionization *** method utilized solid phase extraction（SPE） for sample preparation of the analytes and their deuterated internal standards（ISs） from100 μL human *** chromatography was carried out on Hypurity C_（18） column using acetonitrile-2.0 mM ammonium acetate,pH 5.0（80：20,v/v） as the mobile *** assay exhibited a linear response over the concentration range of 0.200-50.0 ng/mL for ABZ and 3.00-600 ng/mL for *** recoveries of the analytes and ISs ranged from 86.03%-89.66%and 89.85%-98.94%,*** effect,expressed as IS-normalized matrix factors,ranged from 0.985 to 1.042 for the both *** method was successfully applied for two separate studies in healthy subjects using single dose of 400 mg conventional tablets and 400 mg chewable ABZ tablets,respectively.

关键词： Albendazole Albendazole sulfoxide LC-MS/MS Solid phase extraction Bioequivalence study

Selective and rapid determination of raltegravir in human plasma by liquid chromatography–tandem mass spectrometry in the negative ionization mode

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Journal of Pharmaceutical Analysis 2015年第2期5卷 101-109页

作者： Ajay Gupta Swati Guttikar Priyanka A.Shah Gajendra Solanki Pranav S.Shrivastav Mallika Sanyal Chemistry Department Kadi Sarva Vishwavidyalaya Sarva Vidyalaya Campus Sector 15/23 Bioanalytical Research Department Veeda Clinical Research Department of Chemistry School of Sciences Gujarat University Department of Chemistry St.Xavier’s College

A selective and rapid high-performance liquid chromatography–tandem mass spectrometry method was developed and validated for the quantification of raltegravir using raltegravir-d3 as an internal standard（IS）. The analyte and IS were extracted with methylene chloride and n-hexane solvent mixture from 100 mL human plasma. The chromatographic separation was achieved on a Chromolith RP-18 e endcapped C18（100 mm 4.6 mm） column in a run time of 2.0 min. Quantitation was performed in the negative ionization mode using the transitions of m/z 443.1-316.1 for raltegravir and m/z 446.1-319.0 for IS. The linearity of the method was established in the concentration range of 2.0–6000 ng/m *** mean extraction recovery for raltegravir and IS was 92.6% and 91.8%, respectively, and the IS-normalized matrix factors for raltegravir ranged from 0.992 to 0.999. The application of this method was demonstrated by a bioequivalence study on 18 healthy subjects.

关键词： Raltegravir LC–ESI–MS/MS Negative ionization mode Human plasma Bioequivalence study

Preparation and evaluation of transnasal microemulsion of carbamazepine

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Asian Journal of Pharmaceutical Sciences 2013年第1期8卷 64-70页

作者： Sheetal Porecha Acharya K.Pundarikakshudu Aashish Panchal Anita Lalwani l.10.institute of pharmacy and research centre ahmedabadgujarat 382210india kadi sarva vishwavidyalaya sector 15/23gandhinagargujaratindia

The objective of this study was to develop novel transanasl microemulsion containing carbamazepine for treatment of *** acid was selected as oil while Tween 80 and propylene glycol were selected as surfactant and cosurfactant respectively based on solubility *** ratio of Tween 80:propylene glycol was selected after developing pseudoternary phase diagrams for different ratio and microemulsions were *** prepared microemulsions were evaluated for globule size,viscosity,pH,conductivity and%*** diffusion study for optimized microemulsion was performed through sheep nasal mucosa wherein diffusion flux and permeability coefficients were *** pharmacodynamic performance was evaluated in rats by electrically induced *** was found that optimized microemulsion was stable and transparent with average globule size of 190 nm and diffusion flux of 75.77 mg cm2 min1 and showed no toxicity during histopathological evaluation on sheep nasal *** evaluation also indicated lesser intensity of seizures in rats treated with optimized formulation in comparison to rats treated with oral carbamazepine microemulsion and nasal carbamazepine solution which suggested carbamazepine transnasal delivery system as an effective alternate therapy for treatment of epilepsy.

关键词： Carbamazepine Epilepsy Intranasal Microemulsion