scholarly journals Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method

RSC Advances ◽  
2021 ◽  
Vol 11 (45) ◽  
pp. 27820-27831
Author(s):  
Hemanth Kumar Chanduluru ◽  
Abimanyu Sugumaran
Keyword(s):  
Isosorbide Dinitrate ◽  
Method Development ◽  
Quality By Design ◽  
Environmentally Benign ◽  
Analytical Quality ◽  
Stepping Stone ◽  
Hydralazine Hydrochloride

Analysing isosorbide dinitrate and hydralazine by using an eco-friendly method is an initial stepping stone towards environmentally benign method development, and its combination with the AQbD makes it the method to use for ages without revalidation.

Analytical Quality by Design in Stress Testing or Stability - Indicating Method

2021 ◽  
pp. 170-178
Author(s):  
Amitkumar J. Vyas ◽  
Nilam M. Visana ◽  
Ajay I. Patel ◽  
Ashok B. Patel ◽  
Nilesh K. Patel ◽  
...  
Keyword(s):  
Analytical Methods ◽  
Product Life Cycle ◽  
Stress Testing ◽  
Method Development ◽  
Quality By Design ◽  
Systematic Approach ◽  
Storage Condition ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Stability Indicating Method

Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. The concept of QbD can be extended to analytical method development known as analytical quality by design (AQbD). Quality by design is a systematic approach to development that begins with predefined objects and emphasizes product and process understanding and helps in the systematic approach to drug development. The concepts described in ICH Q8- Q11, commonly referred to as quality by design (QbD), have also been applied to the development of analytical methods. The benefits of applying the QbD principle to analytical methods include identifying and minimizing sources of variability that may lead to poor method robustness and ensuring that the method meets its intended performance requirements throughout the product and method lifecycle. Stress testing is a very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in stability-indicating method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities. For determination of degradation pathways and structural elucidation of degradation produced, these stress testing are helpful. It is also used to select the storage condition and improve the manufacturing process of formulations.

scholarly journals Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
N. V. V. S. S. Raman ◽  
Useni Reddy Mallu ◽  
Hanimi Reddy Bapatu
Keyword(s):  
Method Development ◽  
Quality By Design ◽  
Process Analytical Technology ◽  
Assessment Method ◽  
Test Method ◽  
Formulation Development ◽  
Analytical Quality ◽  
Synthetic Process ◽  
Analytical Development ◽  
Quality By Design Approach

Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT (Process Analytical Technology). ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspective. As of now there is no specific requirements for AQbD (Analytical Quality by Design) and PAT in analytical development from all regulatory agencies. In this review, authors have discussed the implementation of QbD and AQbD simultaneously for API synthetic process and analytical methods development. AQbD key tools are identification of ATP (Analytical Target Profile), CQA (Critical Quality Attributes) with risk assessment, Method Optimization and Development with DoE, MODR (method operable design region), Control Strategy, AQbD Method Validation, and Continuous Method Monitoring (CMM). Simultaneous implementation of QbD activities in synthetic and analytical development will provide the highest quality product by minimizing the risks and even it is very good input for PAT approach.

scholarly journals Analytical Quality by Design with the Lifecycle Approach: A Modern Epitome for Analytical Method Development

2019 ◽  
Vol 65 (2) ◽  
pp. 37-44 ◽  
Author(s):  
Maher Abdulrazzaq Alhakeem ◽  
Mihaela Violeta Ghica ◽  
Cristina Dinu Pîrvu ◽  
Valentina Anuța ◽  
Lăcrămioara Popa
Keyword(s):  
Risk Assessment ◽  
Analytical Method ◽  
Method Development ◽  
Quality By Design ◽  
Control Process ◽  
Analytical Techniques ◽  
Analytical Quality ◽  
Comprehensive Knowledge ◽  
Development Concept ◽  
Target Profile

AbstractQuality by Design is the methodical method to development concept that starts with the predefined objects. The method put emphasis on the process of development of a product, the control process, which is built on risk management and comprehensive knowledge of science. The concept of QbD applied to analytical method development is known now as AQbD (Analytical Quality by Design). Comprehension of the Analytical Target Profile (ATP) and the risk assessment for the variables that can have an impact on the productivity of the developed analytical method can be the main principles of the AQbD. Inside the method operable design region (MODR), the AQbD permits the movements of the analytical methods. This paper has been produced to discuss various views of analytical scientists, the comparison with conventional methods, and the phases of the analytical techniques.

Estimation of Glycopyrrolate by Analytical Quality by Design Supported Difference UV Spectrophotometric Method

2018 ◽  
Vol 11 (5) ◽  
pp. 4244-4248
Author(s):  
Sagar Suman Panda ◽  
Ravi Kumar B V V ◽  
Divyakalpa Panda ◽  
Raja Kumar V
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Quality By Design ◽  
Scanning Speed ◽  
Sampling Interval ◽  
Design Approach ◽  
Sample Cell ◽  
Analytical Quality ◽  
Absorbance Maximum ◽  
Quality By Design Approach

A novel difference UV spectrophotometric method was developed and validated for estimation of glycopyrrolate (GLP) in injection formulations using analytical quality by design approach. GLP shows two different absorbance maxima in 0.1M HCl and 0.1M NaOH. Principle of difference spectroscopy was utilized to avoid the variation in absorbance maximum and amplitude of analyte solutions were measured keeping analyte in 0.1M HCl in reference cell and analyte in 0.1M NaOH in sample cell. The amplitude was measured considering maxima at 219nm and minima at 233nm. Further, analytical quality by design approach proved worthy by ensuring method robustness prior to method development. Scanning speed and sampling interval were the two variables which were studied for the robustness purpose using an experimental design. The method validation studies were carried out to evaluate linearity, accuracy, precision, sensitivity etc. The method was applied successfully for estimation of GLP in bulk and present in injections.  

Analytical quality by design for spectrophotometric method development

2021 ◽  
pp. 15-44
Author(s):  
K.K. Lakshmi ◽  
Siddhanth Hejmady ◽  
S. Shridula ◽  
Amit Alexander ◽  
Mukta Agrawal ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Quality By Design ◽  
Analytical Quality
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