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A stability-indicating HPLC assay method for docetaxel
Journal of Pharmaceutical and Biomedical Analysis, 2006A novel stability-indicating high-performance liquid chromatographic assay method was developed and validated for docetaxel in the presence of degradation products generated from forced decomposition studies. A gradient HPLC method was developed to separate the drug from the degradation products, using a Hichrom RPB HPLC column.
B Mallikarjuna, Rao +8 more
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Stability indicating methods for the determination of diloxanide furoate
Journal of Pharmaceutical and Biomedical Analysis, 2002Five new selective, precise and accurate methods are described for the determination of diloxanide furoate (DI) in presence of its degradation products. Method A utilizes the first and second derivative spectrophotometry at 270 and 280 nm, respectively. Method B is a RSD(1) spectrophotometric method based on the simultaneous use of the first derivative
Nagiba Y, Hasan +3 more
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Stability‐indicating chemometric methods for the determination of tazarotene
Drug Testing and Analysis, 2010AbstractTwo multivariate calibration methods—principal component regression (PCR) and partial least square (PLS)—have been used to determine tazarotene in the presence of its degradation products. Both methods are useful in spectral analysis because of the simultaneous inclusion of many spectral wavelengths instead of the single wavelength used in ...
Ahmed S, Saad +3 more
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Stability-indicating methods for the spectrophotometric determination of norfloxacin
Journal of Pharmaceutical and Biomedical Analysis, 1998Two spectrophotometric procedures for the selective determination of norfloxacin (NF) in the presence of its decarboxylated degradant are described. The first depends upon measurement of the pH-induced absorbance difference (delta A) of the drug solution between 0.1 N HCl and 0.1 N NaOH at 280 nm.
S Z, el Khateeb, S A, Razek, M M, Amer
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Stability indicating HPTLC method for the estimation of estradiol
Journal of Pharmaceutical and Biomedical Analysis, 2000Estradiol (ESD) is widely used in post climacteric replacement therapy. Most of the methods used for quantitation are expensive and time consuming. A rapid, selective and precise stability indicating high performance thin layer chromatography method was developed and validated for the estimation of ESD in bulk and pharmaceutical dosage forms.
P N, Kotiyan, P R, Vavia
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Development of Stability Indicating Methods
2009The evaluation of the chemical stability studies of small molecule pharmaceuticals rely primarily on the availability of a chromatographic or other separation assay capable of separating and quantifying major impurities and degradation products.
Anne-Françoise Aubry +2 more
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A stability-indicating HPLC assay method for budesonide
Journal of Pharmaceutical and Biomedical Analysis, 2001The official (European) pharmacopeial assay for budesonide was found to be non-specific and non-stability-indicating when used to qualify several batches of pharmaceutical grade drug substance from different sources. In contrast, the most widely cited HPLC method in the literature was found to be specific and stability-indicating with respect to drug ...
S, Hou, M, Hindle, P R, Byron
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Stability indicating assays for the determination of piroxicam—comparison of methods
Journal of Pharmaceutical and Biomedical Analysis, 1999Photodegradation of piroxicam, a 1,2-benzothiazine oxicam, is studied laying special emphasis on the investigation of the correlation between concentration of the sample solution and stability. A comparison of three different methods (HPTLC/densitometry, HPLC, CE) developed for the photostability testing of the title compound is presented.
Bartsch, Herbert +2 more
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Brazilian requirements for stability indicating methods
TrAC Trends in Analytical Chemistry, 2018Abstract Stability studies guarantees that quality attributes will be maintained during a period under the influence of a variety of environmental factors, consequently maintaining drug product efficacy and safety. In this context, stability indicating analytical methods (SIAM) appears as a regulatory requirement to detect common observed impurities ...
Ana Cerúlia Moraes do Carmo +2 more
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Stability‐Indicating Methods for the Determination of Lansoprazole
Spectroscopy Letters, 2005Abstract Three methods were presented for the determination of lansoprazole in presence of its acid‐induced degradation products. The first method was based on measuring the peak amplitude at 284 nm of the first derivative curve of lansoprazole. The second method was based on the separation of lansoprazole from its degradation products by thin‐layer ...
Zeinab A. El‐Sherif +3 more
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