Nowa wersja platformy, zawierająca wyłącznie zasoby pełnotekstowe, jest już dostępna.
Przejdź na https://bibliotekanauki.pl
Preferencje help
Widoczny [Schowaj] Abstrakt
Liczba wyników

Znaleziono wyników: 2

Liczba wyników na stronie
first rewind previous Strona / 1 next fast forward last
Wyniki wyszukiwania
Wyszukiwano:
w słowach kluczowych:  degradation study
help Sortuj według:

help Ogranicz wyniki do:
first rewind previous Strona / 1 next fast forward last
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 (Rf 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.
EN
A simple, specific, sensitive, precise, accurate, and robust stability-indicating reversed-phase liquid chromatographic (LC) method has been established for analysis of pitavastatin calcium in tablet dosage forms. LC separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, C18 column with acetonitrile-water-triethylamine 80:19.8:0.2 (υ/υ), adjusted to pH 3.5 ± 0.05 with orthophosphoric acid as isocratic mobile phase at a flow rate of 1.5 mL min-1. Detection, with a photodiode-array detector, was at 238 nm, the wavelength of maximum absorbance in a spectrum obtained from its solution in methanol. The retention time was approximately 5.70 min. The method was validated for linearity, accuracy, precision, limits of detection and quantification, and robustness. Quantification was performed over the concentration range 0.1–2.5 μg mL-1. Mean recovery was 100.26 ± 0.75%. The limit of detection (LOD) was 0.0055 µg mL-1. The method was successfully used for analysis of pitavastatin calcium in tablets and for stability studies, because the method separates pitavastatin calcium from its degradation products and from excipients.
first rewind previous Strona / 1 next fast forward last
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.