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

Author(s):  
Amitkumar J. Vyas ◽  
Nilam M. Visana ◽  
Ajay I. Patel ◽  
Ashok B. Patel ◽  
Nilesh K. Patel ◽  
...  

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.

2019 ◽  
Vol 83 (1) ◽  
pp. 65-75 ◽  
Author(s):  
Jéssica B. Ellwanger ◽  
Nathalie Ribeiro Wingert ◽  
Nadia Maria Volpato ◽  
Cássia Virginia Garcia ◽  
Elfrides E. S. Schapoval ◽  
...  

2021 ◽  
Vol 11 (3) ◽  
pp. 126-131
Author(s):  
Maher Abdulrazzaq Al-hakeem ◽  
Lacramioara Popa ◽  
Cristina Dinu-Pirvu ◽  
Mihaela Violeta Ghica ◽  
Razvan Prisada

2020 ◽  
Vol 58 (9) ◽  
pp. 844-858
Author(s):  
Sivaganesh Bommi ◽  
Subbalakshmi Jayanty ◽  
Satyanarayana Raju Tirumalaraju ◽  
Sivasankar Bandaru

Abstract Sacubitril (SBT) is a neprilysin inhibitor, approved by food and drug administration (FDA) in 2015, under the FDA’s priority review process. In this work, we report the validated stability indicating method of SBT by employing quality by design (QbD) principles related to analytical method development, capable in separation of 11 impurities. Chromatographic separation was performed on an ascentis phenyl hexyl column using 10 mM KH2PO4 as a mobile phase-A and the pH adjusted to 2.1. Methanol: acetonitrile (70:30 v/v) solvent mixture was employed as the mobile phase-B in a gradient mode of elution at a flow rate 0.8 mL/min at 30°C. The column effluents were monitored by a photo diode array detector set at a wavelength of maximum absorption 254 nm noted for all the impurities and furthermore for SBT. This method was remarked to be accurate in the range from 92 to 116%, precise with relative standard deviation 0.9% for SBT (0.8 mg/mL) and 1.0 to 2.1% for its related impurities (0.0005 mg/mL) also linear with correlation coefficient r ≥ 0.9989. The limits of quantification for all impurities were 0.05% with respect to sample concentration 0.8 mg/mL. The developed method revealed a good method operable design range for the experimental chromatographic conditions. Forced degradation of SBT carried under acidic, basic and oxidative stressed conditions manifested that the method is stability indicating.


Author(s):  
Punna Venkateshwarlu ◽  
Mehul M. Patel

This article reviews the various analytical methods reported so far in the literature for the determination of stability and impurity profile the lenalidomide and palbociclib anti cancer drugs in single or combination with other drugs in bulk, pharmaceutical dosage forms, biological fluids, stability indicating and impurity profiling methods. The analytical methods used for the estimation of lenalidomide and palbociclib anticancer drugs reviewed in this paper includes ultraviolet spectrophotometry,high performance liquid chromatography (HPLC) ,ultra performance liquid chromatography (UPLC) ,liquid chromatography-mass spectrometry (LC-MS) and electrophoresis. This review focus on the effect of all chromatographic parameters so as to provide as fast, reliable and cost effective methodology of testing. Method development is the process of proving that analytical method is acceptable for use to measure the concentration of active pharmaceutical ingredient in a specific compound dosage form which must be validated to provide reliable data for regulatory submissions. This reviewed is mainly on analytical method development and validation, stability indicating methods, simultaneous estimation methods and bioanalytical methods. The review covers the time period from 2007 to 2019 during which analytical methods including all types of spectrophotometric and chromatographic techniques were reported. The Review covers lenalidomide and palbociclib API and formulation analytical and bioanalytical methods.


RSC Advances ◽  
2021 ◽  
Vol 11 (45) ◽  
pp. 27820-27831
Author(s):  
Hemanth Kumar Chanduluru ◽  
Abimanyu Sugumaran

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.


Sign in / Sign up

Export Citation Format

Share Document