A Review: Stability Indicating Forced Degradation Studies

Sutar, Shubhangi V.; Yeligar, Veerendra C.; Patil, Sangram H.

doi:10.5958/0974-360x.2019.00152.5

Cited by 13 publications

(6 citation statements)

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“…The creation of a reliable stability indicating method offers a reliable foundation for pre-formulation research, stability investigations, and the maintenance of safe drug substance and drug product during storage conditions. 4 survey of the literature finds that the term "stability-indicating" was used to describe many different techniques that were described during the course of the last three to four decades. Most documented approaches, nevertheless, don't quite measure up to the standards set by the law at the moment.…”

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confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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This article provides an overview on Development and Validation of Force degradation study with Stability Indicating Methods (SIMs) for drug substances. Different stress conditions (hydrolysis, oxidation, thermal, and photolytic conditions) are applied to drugs compounds during a process known as forced degradation, and as a result, various degradation products are created. The major purpose of these investigations is to assess a molecule's stability under accelerated settings. It is well recognized that the stability of molecules affects the regulatory documentation process, the choice of appropriate storage and packaging conditions, and the choice of formulation. The deficiencies of reported methods in terms of regulatory requirements are highlighted. This article is to provide appropriate International conference of harmonization (ICH) criteria for force degradation study and to discuss the methodical process for creating verified SIAMs. The aspects of Mass balance in SIMs are discussed and technique used in SIMs were highlighted. Recent advance in stability indicating methods include characterization of degrdant sample and in-vitro toxicity prediction are addressed. Background of force degradation study with stability indicating methods with respect to international author and national author are discussed.

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confidence: 99%

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Chandramore

Sonawane

2022

Biosci., Biotech. Res. Asia

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“…Stability of EBS and GZP was carried out by forced degradation study. [32][33] The chromatograms of samples degraded with acid, base, hydrogen peroxide and light showed well separated spots of pure EBS and GZP as well as some additional peaks at different Rt values. The method is successively applied to pharmaceutical formulation; No chromatographic interferences from the tablet excipients were found.…”

Section: Assay Of Marketed Formulationmentioning

confidence: 98%

Eco-Friendly Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Quality by Design Approach

Bhangale,

Somwanshi,

Kotade

et al. 2023

J. Adv. Zool.

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Introduction: The pharmaceutical industry faces a significant problem as a result of the worldwide requirement to modify processes in order to comply with the green analytical chemistry (GAC) requirements. An enormous amount of organic hazardous waste is produced by high-performance liquid chromatography (HPLC), one of the methods employed the most frequently at different stages in the pharmaceutical sector. Aim: To develop analytical quality by design-aided stability indicating green high-performance liquid chromatography (HPLC) method for estimation of Elbasvir and Grazoprevir in a dosage form. Material and Methods: The critical chromatographic factors were the % of ethanol in the mobile phase, flow rate, and their overall effect on the responses like asymmetry, theoretical plates, and resolution were studied to optimize the method. Green analytical chemistry (GAC) has mainly focused on developing analytical methods that are safe for the environment. Therefore, it is imperative that the GAC principles be applied in pharmacological analysis. A rotatable central composite design was employed, and the optimized conditions for chromatographic separation were made with a run time of 5 minutes using Zorbax C18 column (4.6× 150 mm, 5 µm) with 0.1% Trifluoroacetic acid and ethanol (40:60 v/v) as components of a mobile phase, flowing at a rate of 1.0 ml/minute. Photodiode array detection was carried out at 253 nm. Results: The retention time was 1.8 min for EBS and 2.84 min for GZP. According to the ICH guidelines, the proposed method was validated and stress studies revealed that Elbasvir and Grazoprevir are prone to acidic, basic, and oxidation stress conditions. An analytical eco-scale score evaluated the greenness profile and a software-based evaluation. Conclusion: The developed HPLC method is eco-friendly and shall be adopted in the routine quality control of Elbasvir and Grazoprevir in a tablet dosage form.

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“…This approach ensures the method's robustness and applicability to bulk and pharmaceutical dosage forms, filling a gap in existing literature. 22…”

Section: Comparison With Previous Studiesmentioning

confidence: 99%

A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application

Chavan,

Gandhimathi

2023

IJPQA

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Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.

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A Review: Stability Indicating Forced Degradation Studies

Cited by 13 publications

References 0 publications

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Overview on Development and Validation of Force Degradation Studies with Stability Indicating Methods

Eco-Friendly Stability Indicating HPLC Method for Estimation of Elbasvir and Grazoprevir by Quality by Design Approach

A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application

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