Stress degradation studies and development of validated stability indicating densitometric method for estimation of alpha lipoic acid in bulk and capsule dosage form

• Autorzy: Srivastava Shruti , Dhaneshwar Suneela , Kawathekar Neha

Identyfikatory

DOI

10.1556/1326.2022.01034

• Języki publikacji: EN

Abstrakty

EN

A precise, sensitive, specific and accurate stability indicating densitometric method was developed and validated for alpha-lipoic acid (ALA) in bulk and capsule dosage form. The study employed pre-coated silica gel 60F₂₅₄ TLC plates as stationary phase and toluene: chloroform: methanol: formic acid (5:3:1:0.05; v/v/v/v) as mobile phase. The developed method furnished compact spots of alpha-lipoic acid (R_f 0.28 ± 0.05) after derivatization, offered good linearity in range 80–400 ng/spot with correlation coefficient of 0.998. The values for detection and quantitation were found 18.022 and 54.612 ng/spot respectively. ALA was subjected to stress degradation studies and total 13 degradation products were resolved. Thus, the proposed method offered good results according to ICH guidelines, and can be used for identification, routine quantitative determination as well as for monitoring the stability of ALA in bulk and in capsules.

Słowa kluczowe

EN

chromatography; dithiolane; degradation study; ICH guideline; thioctic acid

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 2
• Strony: 180--186
• Opis fizyczny: Bibliogr. 24 poz., rys., tab., wykr.

Twórcy

autor

Srivastava Shruti

• Department of Pharmaceutical Chemistry, Amity Institute of Pharmacy, Lucknow, Amity University Uttar Pradesh, Noida, U.P., India

autor

Dhaneshwar Suneela

• Department of Pharmaceutical Chemistry, Amity Institute of Pharmacy, Lucknow, Amity University Uttar Pradesh, Noida, U.P., India

• https://orcid.org/0000-0001-7646-642X

autor

Kawathekar Neha

• Department of Pharmacy, SGSITS Indore, Madhya Pradesh, 452003, India

Bibliografia

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