formulation analysis
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2021 ◽  
Vol 8 (11) ◽  
pp. 431-440
Author(s):  
Michelle Eulalia Jones ◽  
Alfianida Wulandari ◽  
Ubaidillah .

PT. Karya Inti Abadi Kontainer, trademark ‘I-CONT,’ is a container modification company creating business stalls with modern, practical and economical containers. We are the solution for MSME business players, which is focusing on the food and beverage industry. Aside from that, we also provide services in membership from consultation, modification containers, delivery, maintenance, service until reselling and remodification. The strategy method uses the Value Proposition Canvas, IFE, EFE, VRIO, CPM, SWOT, IE, QSPM, Porter's Generic Strategy and Lean Business Canvas Model. The results of this analysis can help to determine a suitable business model for PT. Karya Inti Abadi. Keywords: Value Proposition Canvas, Porter's Generic Strategy, Lean Business Model Canvas, containers.


Author(s):  
Potturi. Rama Devi ◽  
Kantipudi Rambabu

Aims: Study on degradation of Capecitabine and Docetaxel based on a new, validated method using UPLC. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: With a flow rate of 1 mL/min and a wave length of 255 nm, the proposed method successfully separated the target metabolite using a Symmetry C18 column (150 mm x 4.6mm,3.5 µm), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) as the mobile phase. The retention times for Capecitabine and Docetaxel were 1.223 minutes and 1.864 minutes, respectively. The isocratic chromatography procedure took about ten minutes to complete at room temperature. Results: The analysis was completed in three minutes with a concentration range of 5-75 µg/mL capecitabine and 2-30 µg/mL docetaxel that was honest in linearity. The system's suitability parameters were examined mathematically, and the outcomes fell within acceptable ranges. Stages with regression coefficients of 0.999 were used in the linear analysis. Capecitabine's LOD and LOQ concentrations were 1.5 µg/mL and 5 µg/mL, respectively, while Docetaxel was 0.6 µg/mL and 2 µg/mL. 98-102% of the drug was recovered, which means the recovery was within acceptable limits. Conclusion: The approach was found to be suitable for bulk and formulation analysis after the validation results were satisfactory. According to ICH guidelines, the recommended procedure was found to be justified.


Author(s):  
Gunturu. Raviteja ◽  
Kantipudi Rambabu

Aims: New validated method for the estimation of Mobocertinib using HPLC and study of its degradation. Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an X-bridge phenyl column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (60:40 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 224 nm. Mobocertinib had a retention time of 2.271 minutes. The isocratic chromatography was performed at room temperature and took approximately five minutes to complete. Results: Analysis was achieved within 5 min over an honest linearity within the concentration range from 6-90 µg/ml of Mobocertinib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.075μg/ml and 0.248 g/ml for Mobocertinib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.


Author(s):  
Syed. Rafi ◽  
Kantipudi Rambabu

Aims: New validated method for the estimation of  Trilaciclib using HPLC and study of its degradation Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021. Methodology: Using an inertsil ODS column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (50:50 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 220 nm. Trilaciclib had a retention time of 4.358 minutes. The isocratic chromatography was performed at room temperature and took approximately six minutes to complete. Results: Analysis was achieved within 6 min over an honest linearity within the concentration range from 3-45 µg/ml of Trilaciclib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.038 μg/ml and 0.124 g/ml for trilaciclib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits. Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.


Author(s):  
Daniel Guerra Vale da Fonseca ◽  
Amanda Danielle Oliveira da Silva Dantas ◽  
André Felipe Oliveira de Azevedo Dantas ◽  
André Laurindo Maitelli

2021 ◽  
Vol 8 (9) ◽  
Author(s):  
Sayed M. Derayea ◽  
Ramadan Ali ◽  
Ahmed A. Abu-hassan

Duloxetine is an antidepressant that exhibits its action by preventing the reuptake of serotonin and norepinephrine by neurons. In this analytical study, we developed two facile, sensitive methods for duloxetine analysis. Both methods rely on the formation of binary association complex between erythrosine-B and duloxetine in an acidic medium using spectrofluorimetric and resonance Rayleigh scattering (RRS) techniques. Spectrofluorimetric method simply uses the quenching property of the formed complex on the native fluorescence of erythrosine-B at an emission wavelength of 557.2 nm ( λ ex = 528.6), while RRS is based on detecting the enhancement in the RRS signal at 357.2 nm. The proposed methods have been validated according to the International Conference on Harmonization guidelines. The approaches provide linear assay of duloxetine hydrochloride over 0.1–2.4 µg ml −1 and 0.2–2.0 µg ml −1 for spectrofluorimetric and RRS methods, respectively. Variables affecting methods and complex formation were studied and optimized. The limit of detection values were 0.03 and 0.056 µg ml −1 for spectrofluorimetric and RRS methods, respectively. Both approaches were applied with acceptable results for formulation analysis and evaluation of cymbatex capsule content uniformity.


2021 ◽  
Vol 8 (8) ◽  
pp. 568-576
Author(s):  
Erna Setiyawati ◽  
Andhika Saputra ◽  
Rhian Indradewa

Background – PT Oesodo Alam Mandiri (PT OAM) is a startup company that was established to provide solutions to business opportunities and problems that are being faced by people in Indonesia. Before starting a business, it is necessary to analyze both internal and external factors, also carry out strategy formulation. The results of this analysis will assist in determining the right strategy and business model. Through the right strategy and business model, a newly established startup company will be able to compete and be sustainable. Method – Using Value Proposition Canvas, EFE, IFE, VRIO, CPM, SWOT, IE, QSPM, Porter’s Generic Strategy and Lean Business Canvas Model. Result – This analysis helps to determine the right business model for jamu partnership startup company. Keywords: Startup, Value Proposition Canvas, Lean Business Model Canvas, Jamu, Indonesia.


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