ABSTRACT
This paper describes sensitive, accurate and precise spectrophotometric, TLC-spectrodensitometric and high performance liquid chromatographic (HPLC) methods for simultaneous determination of olanzapine and fluoxetine HCl. Two spectrophotometric methods were developed, namely; first derivative (D (1)) and derivative ratio (DD (1)) methods. The TLC method employed aluminum TLC plates precoated with silica gel GF254 as the stationary phase and methanol:toluene:ammonia (7:3:0.1, by volume) as the mobile phase, where the chromatogram was scanned at 235 nm. The developed HPLC method used a reversed phase C18 column with isocratic elution. The mobile phase composed of phosphate buffer pH 4.0:acetonitrile:triethylamine (53:47:0.03, by volume) at flow rate of 1.0 mL min(-1). Quantitation was achieved with UV detection at 235 nm. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The selectivity of the proposed methods was tested using laboratory-prepared mixtures. The developed methods were successfully applied for the determination of olanzapine and fluoxetine HCl in bulk powder and combined capsule dosage form.
ABSTRACT
Stability-indicative determination of ertapenem (E(RTM)) and imipenem (I(MPM)) in the presence of their corresponding open-ring degradation products, the metabolites, is investigated. The degradation products have been isolated via acid-degradation, characterized, and confirmed. Selective quantification of E(RTM) or I(MPM) singly in bulk form, pharmaceutical formulations, and/or in the presence of their corresponding degradants is demonstrated. The indication of stability has been undertaken under conditions likely to be expected at normal storage conditions. Among the chromatographic techniques adopted for quantification are coupled thin layer chromatography-densitometry and high-performance liquid chromatography.
Subject(s)
Imipenem , beta-Lactams , Chromatography, High Pressure Liquid , Chromatography, Thin Layer , Drug Stability , Ertapenem , Imipenem/analysis , Imipenem/chemistry , Kinetics , Linear Models , beta-Lactams/analysis , beta-Lactams/chemistryABSTRACT
Stability-indicative determination of ertapenem (ERTM) in the presence of its beta-lactam open-ring degradation product, which is also the metabolite, is investigated. The degradation product has been isolated, via acid-degradation, characterized and elucidated. Selective quantification of ERTM, singly in bulk form, pharmaceutical formulations and/or in the presence of its major degradant is demonstrated. The indication of stability has been undertaken under conditions likely to be expected at normal storage conditions. Among the spectrophotometric methods adopted for quantification are first derivative ((1)D), first derivative of ratio spectra ((1)DD) and bivariate analysis.
Subject(s)
Anti-Bacterial Agents , Spectrometry, Fluorescence/methods , beta-Lactams , Algorithms , Anti-Bacterial Agents/chemistry , Anti-Bacterial Agents/metabolism , Ertapenem , Molecular Structure , Reproducibility of Results , Spectrometry, Fluorescence/instrumentation , beta-Lactams/chemistry , beta-Lactams/metabolismABSTRACT
Stability-indicative determination of meropenem (MERM) in the presence of its open-ring degradation product, the metabolite, is investigated. The degradation product has been isolated, via acid-degradation, characterized and confirmed. Selective quantification of MERM, singly in bulk form, pharmaceutical formulations and/or in the presence of its major degradate is demonstrated. The indication of stability has been undertaken under conditions likely to be expected at normal storage. Among the analytical techniques adopted for quantification are spectrophotometry [first-derivative ((1)D), first-derivative of ratio spectra ((1)DD) and bivariate analysis], as well as chromatography [coupled TLC-densitometry and HPLC].
