Pharmaceutical Methods最新文献_第4页

Development and Validation of a Novel Stability Indicating UVSpectrophotometric Method for Estimation of Febuxostat in Bulk and Pharmaceutical Formulation (Tablets) 一种新的稳定性指示紫外分光光度法测定原料药和制剂(片剂)中非布司他含量的建立与验证

Pharmaceutical Methods Pub Date : 2017-10-15 DOI: 10.5530/PHM.2018.1.5

M. Kaur, P. Bhardwaj, Baldeep Kaur, A. Sharma, C. Kaur, R. Kumar

引用次数: 4

Design, Formulation and Evaluation of Pravastatin Fast Dissolving Tablets. 普伐他汀快溶片的设计、处方及评价。

Pharmaceutical Methods Pub Date : 2017-10-15 DOI: 10.5530/PHM.2018.1.4

J. S. Kumar, R. Gunda

{"title":"Design, Formulation and Evaluation of Pravastatin Fast Dissolving Tablets.","authors":"J. S. Kumar, R. Gunda","doi":"10.5530/PHM.2018.1.4","DOIUrl":"https://doi.org/10.5530/PHM.2018.1.4","url":null,"abstract":"Objective: The main objective of present research investigation is to formulate the Pravastatin Fast Dissolving tablets. Pravastatin, a newer antihyperlipidemic agent, belongs BCS class-III agent and used to treat hypercholesterolemia and to reduce the risk of Cardiovascular disease. Methods: The Fast Dissolving tablets of Pravastatin were prepared employing various concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrants by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50% ,t90% were selected as dependent variables. Results and Discussion: Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, In-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F1) containing combination of 8% Crospovidone and 8% Croscarmellose, is the most similar formulation (similarity factor f2= 89.724, dissimilarity factor f1= 1.307 & No significant difference, t= 0.0465) to marketed product (PRAVACHOL-40). Conclusion: The selected formulation (F5) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be NonFickian Diffusion Super Case-II Transport (n= 1.875).","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"47 1","pages":"16-23"},"PeriodicalIF":0.0,"publicationDate":"2017-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90830766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 11

Development and Validation of Analytical Method for Simultaneous Estimation of Bupivacaine and Meloxicam in Human Plasma Using UPLC-MS/MS UPLC-MS/MS同时测定人血浆中布比卡因和美洛昔康含量的方法建立及验证

Pharmaceutical Methods Pub Date : 2017-10-15 DOI: 10.5530/PHM.2018.1.2

K. Siddareddy, M. A. U. Reddy, B. Suresh, J. Sreeramulu

{"title":"Development and Validation of Analytical Method for Simultaneous Estimation of Bupivacaine and Meloxicam in Human Plasma Using UPLC-MS/MS","authors":"K. Siddareddy, M. A. U. Reddy, B. Suresh, J. Sreeramulu","doi":"10.5530/PHM.2018.1.2","DOIUrl":"https://doi.org/10.5530/PHM.2018.1.2","url":null,"abstract":"Bupivacaine HCl (BP) and Meloxicam (ME) are used as intra-operative local anesthesia and non-steroidal anti-inflammatory drugs respectively. A simple, rapid, selective and sensitive ultra pressure liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for simultaneous quantification of BP and ME in human plasma. By following a simple protein precipitation with solvent mixture containing Water:Acetonitrile:Formic Acid (76:24:0.1,v/v/v), the analytes and internal standards were separated on Acquity HSS T3 column (2.1 x 50 mm, 1.8 μm). Chromatographic Mobile phase A consist of 10 mM Ammonium Formate and Mobile phase B consist of a mixture of Acetonitrile:water:Formic acid (96:5:0.2, v/v/v). Bupivacaine-d9 (BUd9) used as internal standard for BP and C,d3 Meloxicam (ME cd3) used for ME. The concentration of BP and ME were determined by gradient UPLC-MS/MS in Multiple reaction mode (MRM). The mass transition ion-pair for BP was m/z 289.3→140.0 and BUd9 was 298.3→ 149.0, for ME was m/z 352.1→115.0 and ME cd3 was 356.1→115.0, respectively. The proposed method was linear in the range 10 4500 ng/mL. The intra and inter-run precision values are within 6.8 % at a lower limit of quantization level. The overall recovery for both analytes found 98%. The total run time of the method is 2.5 min.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"56 1","pages":"02-08"},"PeriodicalIF":0.0,"publicationDate":"2017-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79441042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 8

Validated Stability-indicating NP-HPTLC/Densitometry Method for the Assay of Zolpidem Tartrate in Pharmaceutical Dosage Form 稳定性指示的NP-HPTLC/密度法测定药剂型酒石酸唑吡坦的含量

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.14

Mohammad Mujeeb G Khan, A. Shirkhedkar

{"title":"Validated Stability-indicating NP-HPTLC/Densitometry Method for the Assay of Zolpidem Tartrate in Pharmaceutical Dosage Form","authors":"Mohammad Mujeeb G Khan, A. Shirkhedkar","doi":"10.5530/PHM.2017.8.14","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.14","url":null,"abstract":"Background: A simple, precise stability-indicating NormalPhase Thin-Layer Chromatography (NPTLC)/ Densitometry method has been studied for estimation of zolpidem tartrate in bulk and in tablet formulation. Method: The chromatographic separation was accomplished on aluminium backed precoated silica gel 60 F254S as the stationary phase using Ethyl acetate: Methanol: triethylamine (9: 1: 0.3 v/v) as mobile phase. Densitometric analysis of zolpidem tartrate was achieved at λ max 293 nm. The method was validated for robustness, precision and accuracy. Stress degradation of zolpidem tartrate was carried out under various reaction conditions including acid, base, oxidation, photo-degradation and dry heating treatment. Result: This system was found to give compact spot for zolpidem tartrate at Rf value 0.56 ± 0.02. The data of linear regression analysis of zolpidem tartrate indicated a good linear relationship over the range of 300 – 1800. LOD and LOQ found 18.10 and 54.84 ng. Resulted stress drugs were analyzed with the developed TLC/ densitometry method. Conclusion: Statistical analysis proves that the method is repeatable and selective for the estimation of zolpidem tartrate in bulk and in formulation. As the method could effectively separate the drug from its degradation products, it can be employed as a stabilityindicating method.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"58 1","pages":"87-91"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75177864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Quality-By-Design Approach to Stability Indicating RP-HPLC Analytical Method Development for Estimation of Canagliflozin API and Its Validation 卡格列净原料药评价的RP-HPLC分析方法建立及验证

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.15

Mohammad Tarikul Islam Bossunia, Khandokar Farjana Urmi, C. K. Shaha

引用次数: 16

Synthesis and Evaluation of Antipsychotic Compounds from Lupeol 芦皮醇类抗精神病化合物的合成与评价

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.13

A. Wal, R. Srivastava, A. Rai, P. Wal, R. Tiwari

{"title":"Synthesis and Evaluation of Antipsychotic Compounds from Lupeol","authors":"A. Wal, R. Srivastava, A. Rai, P. Wal, R. Tiwari","doi":"10.5530/PHM.2017.8.13","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.13","url":null,"abstract":"Aim: The current study was designed to evaluate the antipsychotic potential of lupeol and their semisynthetic derivatives to get a new and potent antipsychotic agent. Methodology: Lupeol was isolated from bark of Crateava nurvala. the current study was designed to evaluate the antipsychotic potential of lupeol and its semisynthetic derivatives. C. Nurvala stem bark was extracted by cold maceration with 95% ethanol and concentrated through rotary vacuum evaporator under reduced pressure. The concentrated ethanolic extract was defatted with petroleum ether and fractionated with chloroform successively. Lupeol derivatives were prepared through a three step reaction with different amines, aliphatic and aromatic moieties. A series of derivatives of lupeol were assayed for antipshychotic activity in actophotometer and compulsive behaviour (Stereotypy) in Plus Maze Model in rats. Few derivatives of lupeol showed more potent activity as compared to the basic molecule, lupeol. Results: The results of the present study clearly indicated that the derivatives and lupeol isolated from C. Nurvala and synthetic lupeol analogs possess significant antipsychotic activity. Conclusion: Lupeol skeleton deserves further investigation for the development of more potent and non-toxic new antipshychotic agents for therapeutic applications.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"25 1","pages":"81-86"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73459862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Dissolution Modulating Mechanism of Flurbiprofen Solid Dispersions: Characterization, Physical Stability and in vivo Performance: Formulation Considerations and optimization study 氟比洛芬固体分散体的溶出调节机制:表征、物理稳定性和体内性能:处方考虑和优化研究

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.20

R. Tiwari, G. Tiwari, Pranaywal, Ankitawal

{"title":"Dissolution Modulating Mechanism of Flurbiprofen Solid Dispersions: Characterization, Physical Stability and in vivo Performance: Formulation Considerations and optimization study","authors":"R. Tiwari, G. Tiwari, Pranaywal, Ankitawal","doi":"10.5530/PHM.2017.8.20","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.20","url":null,"abstract":"Present work studied interaction between Surelease, Urea, and Eudragit RL100 (RL) polymers with nonsteroidal anti-inflammatory drug FLP. Solid dispersions at different weight ratios were prepared by fusion (Method A) and coprecipitation (Method B). Characterization of solid dispersions (SDs) included elemental analysis, Fourier transform (FTIR), Differential scanning calorimetry (DSC), Powder-x-ray diffractometry (XRD), Scanning electron microscopy (SEM) as well as wettability study, angle of repose, aqueous solubility determination, in vitro and in vivo drug release. FTIR studies showed the stability FLP. DSC and XRD studies confirmed the amorphous state of FLP in its SDs. SEM showed the formation of effective SDs of FLP with polymers. Pre-formulation studies showed increased hydrophilicity but a non-significant increase in lipophilicity of the SDs. IDR value is only 0.03±0.001 mg/cm2-min. whereas wettability of solid dispersions was found to be controlled. Angle of repose shows good flowability characteristics. The dissolution rate of FLPSDs prepared by method A was significantly greater than that from method B. Method A with urea and RL provides slower and more gradual increase in dissolution rate than those of FLP, when polymer ratios were increased. TF20 possess longer duration of action compared to FLP.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"38 1","pages":"127-135"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74335827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 3

Modification in the Approach of Developing Solid Dispersed Particles for Enhanced Dissolution 固体分散颗粒增强溶解方法的改进

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.17

Rahul Gupta, A. Mishra, A. Pathak

{"title":"Modification in the Approach of Developing Solid Dispersed Particles for Enhanced Dissolution","authors":"Rahul Gupta, A. Mishra, A. Pathak","doi":"10.5530/PHM.2017.8.17","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.17","url":null,"abstract":"Objective: To use tween 80 with a novel approach of applying a layer over the outer surface of solid dispersion particles for the improvement of the poor results of solubility enhancement by solid dispersion produced by the conventional technique of using surfactant in the matrix form. Methods: The solid dispersed particles of Repaglinide and Polyvinylpyrrolidone K30 were formulated using solvent evaporation method. The surfactant tween 80 was added as matrix forming agent during the solid dispersion and the prepared solid dispersed particles were also allowed to coat with tween 80 just by applying over the surface of container in which solvent was allowed to evaporate. Key findings: It was inferred that tween 80 coated particles were formulated with maximum solubility enhancement of 1982 μg/ml as compared to 103 μg/ml of non coated solid dispersed particles and to 3.82 μg/ml of Repaglinide. The conversion of the crystalline form of drug into an amorphous form was confirmed by DSC, X-RD, FT-IR studies and SEM images. The dissolution study showed that 90% of drug released within 30 min of dissolution. Conclusion: The solubility estimation data confirmed the efficiency of novel approach used for the formulation of particles as the best technique for solubility enhancement over conventional techniques.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"8 1","pages":"108-114"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79408284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Preparation of Transdermal Films of Nifedipine: Ex-vivo and In-vitro Studies 硝苯地平透皮膜的制备:离体和体外研究

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.22

K. Venkateswarlu, C. N. Babu, S. Triveni, B. Kiran

{"title":"Preparation of Transdermal Films of Nifedipine: Ex-vivo and In-vitro Studies","authors":"K. Venkateswarlu, C. N. Babu, S. Triveni, B. Kiran","doi":"10.5530/PHM.2017.8.22","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.22","url":null,"abstract":"Objective: The aim of present study was to prepare and evaluate the transdermal films (TFs) of Nifedipine (NFDP). Methods: The TFs were prepared by solvent evaporation technique and twelve formulations of NFDPTFs were prepared by taking HPMC E15 and Eudragit L100 in different ratios. Polyethylene glycol (15%) and Dimethyl sulfoxide (DMSO) were incorporated as plasticizer and permeation enhancer respectively. DMSO was incorporated in the formulations F7-F12 but it was absent in F1-F6. Results: The prepared TFs were evaluated for weight variation, thickness, folding endurance, drug content, moisture absorption, moisture content determination, mechanical properties and ex-vivo permeation. Mechanical properties revealed that the formulations F4 and F10 were found to be strong enough but not brittle. Hence, the formulations F4 and F10 were selected for ex-vivo studies. The formulations F4 and F10 showed maximum drug permeation within 24 h and formulation with permeation enhancer showed highest drug permeation than formulation without permeation enhancer. Conclusion: It could be concluded that the formulation with permeation enhancer (F10) showed highest permeability through the rat skin than formulation without permeation enhancer.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"15 1","pages":"144-148"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87282702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Formulation Development and Evaluation of Moxifloxacin.HCL Fast Dissolving Tablets 莫西沙星的处方开发与评价。盐酸快溶片

Pharmaceutical Methods Pub Date : 2017-08-15 DOI: 10.5530/PHM.2017.8.24

R. Gunda, J. S. Kumar

{"title":"Formulation Development and Evaluation of Moxifloxacin.HCL Fast Dissolving Tablets","authors":"R. Gunda, J. S. Kumar","doi":"10.5530/PHM.2017.8.24","DOIUrl":"https://doi.org/10.5530/PHM.2017.8.24","url":null,"abstract":"The main objective of present research investigation is to formulate the Moxifloxacin.HCl Fast Dissolving tablets. Moxifloxacin.HCl, a synthetic fluoroquinolone antibacterial agent, and used to treatacute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis. The Fast Dissolving tablets of Moxifloxacin.HCl were prepared employing different concentrations of Crospovidone and Croscarmellose sodium in different combinations as a Superdisintegrants by Direct Compression technique using 32 factorial design. The concentration of Crospovidone and Croscarmellose sodium was selected as independent variables, X1 and X2 respectively whereas, wetting time, Disintegration time, t50%, and t90%were selected as dependent variables. Totally nine formulations were designed and are evaluated for hardness, friability, thickness, Assay, Wetting time, Disintegration time, In-vitro drug release. From the Results concluded that all the formulation were found to be with in the Pharmacopoeial limits and the In-vitro dissolution profiles of all formulations were fitted in to different Kinetic models, the statistical parameters like intercept (a), slope (b) & regression coefficient (r) were calculated. Polynomial equations were developed for Wetting time, Disintegration time, t50%, t90%. Validity of developed polynomial equations were verified by designing 2 check point formulations (C1, C2). According to SUPAC guidelines the formulation (F5) containing combination of 7.5% Crospovidone and 7.5% Croscarmellose, is the most similar formulation (similarity factor f2=68.88, dissimilarity factor f1= 3.35& No significant difference, t= 0.00354) to marketed product (AVELOX-400). The selected formulation (F5) follows First order, Higuchi’s kinetics, mechanism of drug release was found to be Non-Fickian Diffusion Super Case-II Transport (n= 1.902).","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"1 1","pages":"160-167"},"PeriodicalIF":0.0,"publicationDate":"2017-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88160485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 10