[HTML][HTML] Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review

YL Chew, MA Khor, YY Lim - Heliyon, 2021 - cell.com
Stability indicating assay describes a technique which is used to analyse the stability of drug
substance or active pharmaceutical ingredient (API) in bulk drug and pharmaceutical …

[PDF][PDF] Bioanalytical method validation: A comprehensive review

PR Sankar, AS Geethika, G Rachana… - Int. J. Pharm. Sci …, 2019 - researchgate.net
Measurement of drug concentrations in biological matrices (such as serum, plasma, faces,
skin, blood, urine, saliva and other organ tissues) is an important aspect of medicinal …

[PDF][PDF] Applications in HPLC in pharmaceutical analysis

R Sankar, KS Snehalatha, ST Firdose… - International Journal of …, 2019 - researchgate.net
High performance liquid chromatography (HPLC) has been widely used for years as an
analytical method and is a key tool for the separation and analysis of pharmaceutical drugs …

Current trend in performance of forced degradation studies for drug substance and drug product's

R Bhaskar, M Ola, V Agnihotri, A Chavan… - Journal of Drug …, 2020 - jddtonline.info
The stability of a new drug substances and new drug products is a vital parameter which
may affect purity, safety & potency. Changes in drug stability can threat patient safety by …

[HTML][HTML] Overview on Development and Validation of Force degradation studies with Stability Indicating Methods.

K Chandramore, S Sonawane - … Biotechnology Research Asia, 2022 - biotech-asia.org
This article provides an overview on Development and Validation of Force degradation
study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions …

Azobisisobutyronitrile loaded on mesoporous silica particles: A new stressor for solid-state oxidative forced degradation studies

J Petřík, D Zůza, J Heřt, P Řezanka, L Krejčík… - … of Pharmaceutical and …, 2023 - Elsevier
A new approach for testing drug sensitivity to autooxidative degradation in the solid state is
demonstrated in this work. A novel solid-state form of stressing agent for autooxidation has …

[PDF][PDF] Development and validation of novel UV and RP-HPLC methods for determination of cilnidipine (a new generation ca channel blocker) in pharmaceutical …

PR Sankar, V Swathi, PS Babu - Int J Pharm Sci Res, 2019 - academia.edu
An accurate and precise High-Performance Reversed-Phase Liquid Chromatographic and
UV spectrophotometric methods were developed and validated for the quantitative …

Delineation of prototypical degradation mechanism, characterization of unknown degradation impurities by liquid chromatography–quadrupole‐time‐of‐flight–tandem …

S Mishra, N Rajput, T Jadav, NK Panday… - Biomedical …, 2024 - Wiley Online Library
Selumetinib (SELU) was recently approved by the US Food and Drug Administration (US
FDA) in 2020. However, the degradation impurities of SELU have not been characterized or …

[PDF][PDF] Development and validation of UV-spectrophotometric method for determination of sorafenib in pharmaceutical dosage form and its degradation behaviour …

P Ravisankar, PS Babu, SM Taslim… - Int J Pharm Sci Rev …, 2019 - researchgate.net
The objective of this study is a cost effective, precise, accurate, simple stability indicating UV-
Spectrophotometric method was developed for the estimation of Sorafenib in tablet dosage …

The development of forced degradation and stability indicating studies of drugs-a review

A Verma, S Singla, P Palia - Asian Journal of Pharmaceutical Research …, 2022 - ajprd.com
Force degradation study is an essential study that provides the knowledge & judgement to
develop a stability indicating analytical method. This study helps to establish the …