Stability Indicating Forced Degradation Studies

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

doi:10.5958/0974-360x.2019.00078.7

Cited by 8 publications

(1 citation statement)

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“…To avoid further decomposition, the degraded sample is then neutralized using suitable acid, base, or buffering. [37][38] Drug substance of oxidative degradation involves a mechanism for the electron transfer to form reactive anions and cations. Hydrogen peroxide is widely used in forced degradation studies for the oxidation of drug substances but other oxidizing agents such as metal ions, oxygen, and radical initiators may also be used.…”

Section: In the Pre-ind Periodmentioning

confidence: 99%

Importance of LCMS in Forced Degradation Studies for new Chemical Entities

Kota

Valli

2022

Int J Life Sci Pharm Res

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Forced degradation studies shows the chemical behaviour of the molecule which in turn helps in the development of formulation and package. In addition, the regulatory guidance is very general and does not explain about the performance of forced degradation studies. In pharmaceutical industry, mandatory degradation tests are important to determine the mechanisms and measure the potential degradants during the analysis of drug material and to help to elucidate the composition of degradation materials. The Liquid Chromatography/ Mass Spectrum analysis (L.C.M.S) is a short term widely established liquid chromatography and a methodology utilizing a natural fluid process. L.C.M.S. is commonly employed in the laboratories for qualitative testing of drug substances, drugs and biological samples. Degradation studies, metabolic screening, metabolite identity and in vivo drug screening, impurity identification, amide mapping, glycoprotein mapping were consistently used in pharmaceutical development by LCMS. The FDA and ICH guidelines sets out the requirement for stability testing data to understand how the quality of the drug substance and drug product changes over time under the influence of various environmental factors. Knowledge of molecular stability helps to select the correct formulation and package as well as to provide proper storage conditions and shelf life, which is essential for regulatory documentation. Active pharmaceutical ingredients (APIs) may form impurities when exposed to excipients or environmental variables such as light, high temperatures, acidic or basic conditions, humidity; and the oxidative atmosphere. Considering that these impurities may have an impact on safety and efficacy, it is necessary to know how these impurities are produced from the drug product and to establish the path of their formation. In this context, forced drug degradation studies have been used to characterize the physicochemical stability of APIs. These studies are also essential in the validation of analytical methodologies, in order to demonstrate the selectivity of methodologies. The API and its impurities and to develop strategies to avoid the formation of degradation products. The objective of this review is to demonstrate how forced degradation studies have been conducted and application of LCMS tools in related studies.

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Section: In the Pre-ind Periodmentioning

confidence: 99%

Importance of LCMS in Forced Degradation Studies for new Chemical Entities

Kota

Valli

2022

Int J Life Sci Pharm Res

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Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

Vaghasiya

Dudhatra

Vyas

et al. 2021

RJPT

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Stability indicating RP-UPLC photo diode array detector based method for determination of Dapagliflozin propanediol monohydrate (DPM) in active pharmaceutical ingredient (API) and in tablet dosage form (5mg dapagliflozin) has been developed and validated on Bridge Ethylene Hybride (BEH) C18 column (50mm × 2.1 mm, 1.7µm). Mobile phase composition was water: acetonitrile (60:40 v/v), flow rate 0.5ml/min and detection carried out at 223nm at column temperature 30ºC. Chromatographic separation achieved within 2 min with retention time 0.77 min. Linearity of the method was found over the concentration range of 25-75µg/ml (R2 = 0.9977). The degradation was carried out in five different stress conditions. The developed method was able to resolve peak of API from all generated peaks. Sufficient degradation was achieved in the range of 5.25 to 12.31%. The peak purity is acceptable, Method validation was performed as per ICH guideline Q2(R1).

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Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug

Sakariya

Bhaloddiya

Shah

2022

RJPT

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An accurate, precise, robust and selective stability-indicating liquid chromatographic (UPLC) method has been developed for the monitoring of Fidarestat in the presence of its forced degradants. The drug was subjected to hydrolysis (acid and alkali), oxidation, photolysis and thermal stress conditions. The drug degraded significantly under hydrolytic and oxidative stress conditions, whereas it was found to be stable in photolytic and thermal conditions. The mobile phase consisted of 0.1% formic acid and methanol in the ratio of (50:50, v/v). The flow rate was 0.5ml/min, column temperature 30°C, the injec¬tion volume was 20µL, and sample was monitored at 283nm using a PDA detector over a concentration range of 20 - 180μg/ml with correlation coefficient of 0.997. The developed LC method was validated as per ICH guideline Q2 (R1). The proposed method was found to be successively applied for the quality control of Fidarestat in bulk drug analysis.

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Stability Indicating Forced Degradation Studies

Cited by 8 publications

References 0 publications

Importance of LCMS in Forced Degradation Studies for new Chemical Entities

Importance of LCMS in Forced Degradation Studies for new Chemical Entities

Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

Development of a Stability-indicating RP-UPLC Method for determination of Fidarestat in Bulk Drug

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