Stability-indicating method development for quantification of bromopride, its impurities, and degradation products by ultra-high performance liquid chromatography applying Analytical Quality by Design principles

2021 ◽  
pp. 114306
Author(s):  
Juliana Caldeira Abreu ◽  
Amanda Guiraldelli Mahr ◽  
Claudimir Lucio do Lago
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Quality By Design ◽  
Degradation Products ◽  
Design Principles ◽  
Analytical Quality ◽  
Stability Indicating ◽  
Stability Indicating Method

scholarly journals Analytical Quality by Design Approach of Reverse-Phase High-Performance Liquid Chromatography of Atorvastatin: Method Development, Optimization, Validation, and the Stability-Indicated Method

2021 ◽  
Vol 2021 ◽  
pp. 1-12
Author(s):  
Nabil K. Alruwaili
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Flow Rate ◽  
Retention Time ◽  
High Performance ◽  
Method Development ◽  
Quality By Design ◽  
Water Flow Rate ◽  
Pharmacokinetic Parameters ◽  
Analytical Quality

The use of analytical quality by design (AQbD) approach in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool. Three factors and three levels of Box–Behnken statistical design (BBD) were used for method optimization and analysis of atorvastatin. The mobile phase (acetonitrile: water), flow rate (Rt), and UV wavelength were used as independent variables. Their effects were observed in the area of the chromatogram (AU), retention time (Rt, min), and tailing factor (%). The optimized HPLC condition was found as acetonitrile:water (50 : 50), flow rate (0.68 ml/min), and UV wave length (235 nm). It gives the retention time of 2.43 min with the linearity range of 5–30 μg/ml with a high regression value (r2 = 0.999). The method was found to be precise and accurate with low % RSD (<5%). The refrigeration stability indicated that atorvastatin was stable. The force degradation study showed that the atorvastatin was fully unstable in UV light and stable in 0.1 M basic condition. It concluded that this QbD optimized method is suitable for quantification of the atorvastatin from the formulation as well as pharmacokinetic parameters.

scholarly journals STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF METFORMIN AND ERTUGLIFLOZIN BY HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY WITH PDA DETECTION AND ITS APPLICATION TO TABLET DOSAGE FORM

2019 ◽  
pp. 353-358
Author(s):  
KADALI JAGADEESH ◽  
ANNAPURNA N
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Method Development ◽  
Simultaneous Estimation ◽  
Phase System ◽  
Dihydrogen Phosphate ◽  
Response Measurement ◽  
Stability Indicating ◽  
Relative Standard

Objective: A sensitive, rapid, accurate, and precise stability indicating high-performance liquid chromatography method was developed and validated for the simultaneous estimation of metformin (MET) and ertugliflozin (ERT). Methods: The planned chromatographic method was developed using Kromasil C18 column using 0.1 M sodium dihydrogen phosphate methanol (50:50, by volume, pH 4.0) as mobile phase system followed by peak area response measurement at 238 nm. The developed method was validated by means of ICH guidelines about system suitability, linearity, sensitivity, selectivity, accuracy, precision, robustness, and specificity. Results: Calibration curves of MET and ERT are linear from 250 to 750 μg/ml and 3.75 to 11.25 μg/ml, respectively. Relative standard deviation is <2.0% and recovery is ̴ 100%. Successfully, the developed method was applied for the simultaneous determination of MET and ERT in tablets and to study degradation of MET and ERT in acidic, alkaline, oxidation, thermal, and photolytic degradation conditions. No obstructions from additional common excipients of tablets and degradants were observed. Conclusion: The results recommended method suitability for the analysis of MET and ERT in quality control laboratories.

A Review article on Analytical Method Development for the combination of Azelnidipine and Telmisartan

2021 ◽  
pp. 227-234
Author(s):  
Nirma Chavda ◽  
Suresh Kumar
Keyword(s):  
Liquid Chromatography ◽  
Thin Layer ◽  
Thin Layer Chromatography ◽  
High Performance ◽  
Method Development ◽  
Ultra Performance Liquid Chromatography ◽  
Resonance Spectroscopy ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Layer Chromatography

The literature survey explains that there is not any stability indicating method reportedly for combination of Azelnidipine and Telmisartan till date. Validation and development of stability indicating analytical methods is possible as per ICH Guidelines. There are several of Spectroscopic methods such as Ultraviolet Spectroscopy, Mass spectroscopy, infrared spectroscopy, Nuclear magnetic resonance spectroscopy and Chromatographic methods such as High performance liquid chromatography, Thin layer Chromatography, High Performance thin layer chromatography, Gas chromatography and Ultra performance liquid chromatography etc. used for stability indicating method development and validation.

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.

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