FORMULATION DEVELOPMENT AND STABILITY INDICATING HPLC ASSAY OF TABLETS OF APIXABAN

Objective: Cost effective formulation development and stability indicating HPLC method for estimation of apixaban in bulk and tablets dosage form.Methods: 32 factorial design was applied to formulate the immediate release tablets of apixaban by using direct compression method. The chromatographic separation was performed on Purospher Star RP-18e (5 µm, 250x4, 6 mm) column and a stability indicating assay method was developed by using HPLC. The mobile phase consists of water: acetonitrile (60:40 v/v) was delivered at a flow rate of 1 ml/min and UV detection at 280 nm. The method was validated with forced degradation studies as per ICH guidelines.Results: Prepared batches were evaluated for all pre-compression parameters and post-compression parameters. Formulation batch F5 prepared by direct compression shows highest dissolution release of 90.97 % over the period of 60 min while disintegration time was found to be 136 seconds. The retention time of developed HPLC method was found to be 5.66 min. This method was found to be linear in a concentration range of 5-30 μg/ml of the drug (r2= 0.999). The low value of % RSD in the precision study indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The results of forced degradation studies indicated that the drug was less stable in thermal and photolytic condition and degraded in acidic, basic, oxidative conditions.Conclusion: On the basis of formulation evaluation, batch F5 was found to be promising formulation suitable for the immediate release of apixaban. Results obtained by validation studies suggested that the developed stability indicating assay method is simple, accurate, specific, sensitive and precise. Thus, this method can be used for routine analysis of apixaban formulation and to check the stability testing.Â

DEVELOPMENT AND VALIDATION OF HPTLC METHOD FOR DETERMINATION APIXABAN IN BULK AND TABLETS

Objective: To develop a simple and sensitive, high-performance thin layer chromatographic (HPTLC) method for the quantitative estimation of apixaban in bulk and tablets.Methods: Sample of apixaban was applied on silica gel 60 F254 TLC plates under pure nitrogen stream by linomat TLC applicator. Separation was carried out by using toluene, methanol and diethylamine as a mobile phase in a ratio of 16:3:1 v/v/v. Developed TLC plates were scanned by camag TLC scanner and detection was carried out at 288 nm.Results: Rf value of apixaban was found to be 0.4. The linearity was found from 50 to 350 ng/spot. The mean percentage recovery was found to be 85.66with % RSD of 0.79.Conclusion: The present study represents first HPTLC method that deals with the estimation of apixaban. Validation results indicated that the developed method is simple, rapid, accurate, specific, sensitive and precise. The developed method was validated as per ICH Q2 (R1) guideline by studying various validation parameters like accuracy, precision, specificity, assay, LOD and LOQ. It can be concluded that the method can be used in routine analysis of apixaban in tablet dosage form

Reciprocal Effect of Team Commitment and Media Richness in eCollaboration: A Conceptual Model

One of the major areas of E-Business applications is the sourcing of expert human resources globally with the help of virtual teams operating in various parts of the world. Major corporations are increasingly using e-Collaboration technologies to make the functioning of these teams economical and effective. The tasks performed by these teams can vary from software design and development to providing back office services like call center support, technical support, transcription services etc. Additionally, after 9/11 corporations have embarked on major initiatives to implement e-Collaboration technologies at the global level to help reduce travel. Extensive work has been done to study the decision-making performance of face-to-face and virtual teams. However, previous studies have found conflicting results regarding the impact of media richness on decision-making performances of teams. This paper posits the significant role of media type on the communication richness when team members have low commitment to the collaborative team projects. A conceptual model that depicts the influence of media type on satisfaction, team conflict, social influence, and supportiveness that influences the team commitment has been developed. The influence of team commitment on communication richness is also examined. A controlled lab experiment is designed to test the research model

FORMULATION DEVELOPMENT AND EVALUATION OF GASTRO-RETENTIVE DOSAGE FORM OF ATAZANAVIR SULPHATE

Objective: To improve dissolution properties of atazanavir sulphate by preparing gastro-retentive granules by solid dispersion method and development of RP-HPLC method for estimation of this drug.Methods: Estimation of atazanavir sulphate was done using high performance liquid chromatography (HPLC) on inertsil column (5 µm, 250x4, 6 mm) with a mobile phase consists of methanol: water (91:9 v/v), at 0.5 ml/min flow rate and 249 nm UV detection. The method was validated as per ICH guidelines. Selection of the carrier for gastro-retentive formulation was based on phase solubility study of the drug. Solid dispersions of gastro-retentive granules of different composition of drug and carrier, were prepared by the kneading, heating and solvent evaporation. A 32factorial design was applied to optimize the gastro-retentive formulation. The amounts of polyethylene glycol 6000 (PEG 6000) (X1) and hydroxypropyl methyl cellulose (HPMC) (X2) were selected as independent variables and in vitro-release at 5, 9 h and total floating time was selected as dependent variables. Results: HPLC method was found to be linear in a concentration range of 10-60 μg/ml of the drug (r2= 0.999). The low value of % RSD in precision study indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The solubility enhancement study of drug with various carriers followed descending order of solubility [Gelucire 44/14>PEG 6000>polyvinyl pyrrilidone (PVP)]. Highest % cumulative release was observed for the heating method at drug polymer (PEG 6000) ratio 1:5. Hence, this ratio has been selected for preparation of solid dispersion. From comparison of dissolution profile of formulated batches, formulation F4 [containing PEG6000 (1.6 g) and HPMC (200 mg)] showed promising dissolution parameters with desired floating properties.Conclusion: Results obtained by validation studies suggested that the developed HPLC method is simple, accurate, precise and can be used for routine analysis of atazanavir sulphate formulation. Results of evaluation of prepared batches indicate that batch F4 is a promising formulation for gastro-retentive dosage form of drug.Â

Empirical Investigation into Impact of Electronic Commerce Systems Richness on User Behavior: The Case of a Complex Product

There is no doubt that growth of electronic commerce (EC) on the Internet/Web is only going to accelerate even more. However, given that commerce in these environments are virtual in nature and that most consumers feel uncomfortable with this virtuality a more compelling issue is how can the EC environments be made more acceptable to consumers to approximate their real-world physical store purchases behavior. Drawing upon previous literature, this study uses the theme of “fit” between EC environment and the product type, develops four different prototype systems depicting different EC environments, and using laboratory-based experiments examines the influence of “fit” on four user outcomes. Significant support to the “fit” theory is obtained

STABILITY INDICATING RP-HPLC ASSAY METHOD FOR ESTIMATION OF DIMETHYL FUMARATE IN BULK AND CAPSULES

Objective: To develop an accurate, simple, precise and specific stability indicating RP-HPLC method for estimation of dimethyl fumarate in bulk and capsules.Methods: An Inertsil ODS (150x4.6 mm, 5µ) column and a mobile phase containing acetonitrile: potassium dihydrogen phosphate buffer pH 6.8 (50:50% v/v) was used for this study. The flow rate was maintained at 1.0 ml/min; column temperature was fixed at 35 °C and UV detection was carried out at 210 nm. The forced degradation studies were performed and method was validated with as per ICH guidelines.Results: The retention time of dimethyl fumarate was found to be 3.3±0.02 min. The value of correlation coefficient between peak area and concentration was found to be 0.9993. The mean percent recovery of dimethyl fumarate in capsules was found in the range of 99.65 to 101.64%. The results of forced degradation studies indicated that the drug was found to be stable in basic, oxidative and thermal conditions while degraded in acidic conditions.Conclusion: It can be conducted from results that the developed HPLC method is simple, accurate, precise and specific. Results of stress testing study revealed that the method is stability indicating. Thus, this method can be used for routine analysis of dimethyl fumarate capsules and check their stability. Â

Integrating Multiple Criteria Decision-Making Models Into the Decision Support System Framework for Marketing Decisions

The paper focuses on integrating the multiple criteria decision making (MCDM) models within the decision support system (DSS) framework to encourage greater use of these models. A DSS framework and the criteria used for the choice of a model is discussed. Based on these criteria MCDM models generally used in the marketing field are evaluated. The possibility of using a mixture of MCDM models within the DSS framework is also explored. Following this, the role of the MCDM models in DSS is delineated. It is argued that, within the problem-solving process, the confluence of MCDM models and DSS plays a vital role in developing high-quality solutions

EFFECT OFCO-ADMINISTRATION OF EMBLICA OFFICINALIS AND AEGLE MARMELOS EXTRACTS FOR ANTIOXIDANT AND ANTIDIABETIC ACTIVITY

Objective: The objective of the present study was to develop an HPLC analytical method and to perform in vivo study of Emblica officinalis and Aegle marmelos extracts for antioxidant and antidiabetic activity. Methods: The phytochemical analyses, total phenolic content (TPC), TLC, DPPH assay were performed for freeze-dried Emblica officinalis fruits aqueous extract (EOFAE) and Aegle marmelos leaves ethyl acetate extract (AMLEAE). The active constituents present in both extracts were estimated by using HPLC system having Hibar® C18 column [250 x4.6 mm, 5 µm] and UV detector (264 nm). A gradient mobile phase (acetonitrile and water with 0.1% trifluoroacetic acid) was used at a flow rate of 0.8 ml/min. In vivo antioxidant, antidiabetic activity of both extracts was conducted on male albino Wistar rats for 21 d in streptozotocin-induced diabetic rats (42 rats; n=6). The antidiabetic activity was measured by blood glucose level and biochemical parameters i.e. total cholesterol, triglycerides and total protein. Oxidative stress was measured by antioxidant biomarkers i.e. SOD, GSH, lipid peroxidation by thiobarbituric acid reactive substances method on the liver of the experimental rat. Results: Tannins, saponins, carbohydrate, glycosides are found in EOFAE; coumarins and flavonoids are found in AMLEAE and quinones, phenols are present in both extracts. The values of TPC present in standard gallic acid, EOFAE and AMLEAE were found to be 485.7, 315.6, 300.7 mgGAE/g, respectively. Rf values obtained by TLC of EOFAE and AMLEAE were found to be 0.41 and 0.50, respectively. The values of % inhibition shown by EOFAE and AMLEAE in DPPH assay were found to be 97.8%±2 and 95.2%±2, respectively. The values of retention time of EOFAE and AMLEAE by HPLC analysis were found to be 4.59 and 5.28 min, respectively. Histopathological examination of the liver was revealed that low dose EOAM (containing of EOFAE 250+AMLEAE 250 mg/kg body weight) administered once a daily for 21 d showed significant activity (P˂0.001) with biochemical parameters and antioxidant biomarkers. Conclusion: The present study showed that the EOFAE and AMLEAE treated group III with (EOAM) low dose of 500 mg/kg body weight has potent antioxidant and antidiabetic activity

THE ISSUE OF SITE AUTONOMY IN DISTRIBUTED DATABASE ADMINISTRATION

With the increasing trend towards distributed systems, the administration of distributed databases has become very important. A key issue in this environment is the degree of autonomy for each participating site. This paper classifies the degree of site autonomy into three different levels and provides some guidelines for determining the appropriate degree of site autonomy from both organizational and technological perspectives. The alternative organizational structure for database administration and the specific tasks assigned to a Global DBA and Local DBAs under different site autonomy policies is discussed. Finally, the three site autonomy policies are compared

Integrating Multiple Criteria Decision-Making Models Into the Decision Support System Framework for Marketing Decisions

The paper focuses on integrating the multiple criteria decision making (MCDM) models within the decision support system (DSS) framework to encourage greater use of these models. A DSS framework and the criteria used for the choice of a model is discussed. Based on these criteria MCDM models generally used in the marketing field are evaluated. The possibility of using a mixture of MCDM models within the DSS framework is also explored. Following this, the role of the MCDM models in DSS is delineated. It is argued that, within the problem-solving process, the confluence of MCDM models and DSS plays a vital role in developing high-quality solutions