Wyniki wyszukiwania - BazTech

Ograniczanie wyników

2 Acta Chromatographica

Powiadomienia systemowe

Sesja wygasła!

Znaleziono wyników: 2

Liczba wyników na stronie

Wyniki wyszukiwania

Wyszukiwano:
w słowach kluczowych: isocratic reversed-phase liquid chromatography

Sortuj według:

Ogranicz wyniki do:

A validated stability-indicating isocratic LC method for levofloxacin in the presence of degradation products and its process-related impurities

Sateesh J. N., Subba Reedy G. V., Jayaveera K. N., Dhayalamurthi S

Acta Chromatographica

2012

Vol. 24, no. 1

23--36

The objective of the current study is to develop a validated specific stability-indicating isocratic reversed-phase liquid chromatographic method for the quantitative determination of levofloxacin and its related substances in pharmaceutical dosage forms in the presence of degradation products and its process-related impurities. Forced degradation studies were performed on levofloxacin as per the International Conference on Harmonisation (ICH)-prescribed stress conditions using acid, base, oxidative, water hydrolysis, thermal stress and photolytic degradation to show the stability-indicating power of the method. Significant degradation was observed during oxidative stress; minor degradation was observed in acidic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the spiked impurity solution. The analysis was carried out with a 50 mm length × 4.6 mm i.d., 3.0 μm particle size YMC Pack Pro-C18 column using the mobile phase consisting of a mixture of 1.0% (v/v) triethylamine in water with pH adjusted to 6.30, using orthophosphoric acid, methanol and acetonitrile (7.7:1.3:1.0) pumped at a flow rate of 0.8 mL min−1 with ultraviolet (UV) detection at 235 nm. The limit of detection and the limit of quantification for the levofloxacin and its process-related impurities were established. The stressed test solutions were assayed against the qualified working standard of levofloxacin and the mass balance in each case was in between 99.1% and 99.9%, indicating that the developed liquid chromatography (LC) method was a stability-indicating technique. Validation of the developed LC method was carried out as per ICH requirements.

Development and validation of a dissolution method for novel fixed dose combination of etodolac and propranolol hydrochloride tablets by RP-HPLC

Mohan A., Dhayalamurthi S, Anandan P, Saravanan D

Acta Chromatographica

2011

Vol. 23, no. 4

551--566

The present study reports the dissolution method for a novel fixed dose combination (FDC) containing etodolac (ET) and propranolol hydrochloride (PH) developed utilizing USP Apparatus 1 (basket) at 100 rpm with 1000 mL of phosphate buffer (pH 6.8; 0.05 M) medium at 37°C. An isocratic reversed-phase liquid chromatographic (RPLC) method was also developed for the simultaneous determination of ET and PH on an octadecylsilica column using phosphate buffer (pH 5.5) and acetonitrile (60:40, υ/υ) as the mobile phase with ultraviolet (UV) detection at 292 nm. Validation data were obtained, which demonstrated that the dissolution methodology is accurate, precise, linear, and rugged for the combination tablets.