scholarly journals Validated Analytical Method for the Determination of Sorafenib in Dosage form and Human plasma in presence of it Degradation Products

2019 ◽  
Vol 12 (03) ◽  
pp. 08-21
Author(s):  
Wael Talaat ◽  
Mohamed M.Y. Kaddah
Keyword(s):  
Human Plasma ◽  
Analytical Method ◽  
Dosage Form ◽  
Degradation Products

scholarly journals Stability Indicating HPLC Method for the Determination of Delamanid in Pharmaceutical Dosage Form

2021 ◽  
Vol 11 (1-s) ◽  
pp. 108-112
Author(s):  
Advaita B. Patel ◽  
Deepa R. Patel ◽  
Dhaval M. Patel ◽  
Mansi Babaria
Keyword(s):  
Analytical Method ◽  
Mobile Phase ◽  
Dosage Form ◽  
Degradation Products ◽  
Stress Test ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

Delamanid is successfully used for treatment of MDR TB. A stability indicating analytical method has been developed and validated. In this study Delamanid was degraded under different stress test conditions as per International Conference on Harmonization. The degraded samples were used to develop a stability-indicating high performance liquid chromatographic (HPLC) method for the Delamanid. The Delamanid was well separated from degradation products using a reversed-phase Hypersil BDS C18 (250 mm × 4.6mm i.d., 5µm) column and a mobile phase comprising of 0.01M pH 2.70 Phosphate Buffer: Acetonitrile (pH 3.50) 70:30, pH of mobile phase was adjusted with Glacial acetic acid and other HPLC parameters were flow rate 1 mL/min, detection wavelength 254 nm and injection volume 10 µl. The method was validated for linearity, precision, accuracy, ruggedness and robustness. Results obtained after validation study indicating that the proposed single method allowed analysis of Delamanid in the presence of their degradation products formed under a variety of stress conditions. The developed procedure was also applicable to the determination of stability of the Delamanid in commercial pharmaceutical dosage form. Keywords:  Delamanid, stability indicating analytical method, HPLC

HPTLC-Densitometric Determination of Allopurinol and its Metabolite Oxypurinol in Human Plasma and Allopurinol in Tablet Dosage Form

2018 ◽  
Vol 8 (4) ◽  
pp. 537-551 ◽  
Author(s):  
Jui J. Pandya ◽  
Mallika Sanyal ◽  
Priyanka A. Shah ◽  
Pranav S. Shrivastav
Keyword(s):  
Human Plasma ◽  
Dosage Form ◽  
Tablet Dosage

Development and Validation of Two Robust Stability-Indicating Chromatographic Methods for Determination of Metolazone in Drug Substance and Pharmaceutical Dosage Form in the Presence of Its Degradation Products and Characterization of Main Degradation Products Based on LC-MS

2019 ◽  
Vol 58 (3) ◽  
pp. 251-261
Author(s):  
Hala E Zaazaa ◽  
Rasha Abdel-Ghany ◽  
M Abdelkawy ◽  
Mahmoud Sayed
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Hplc Method ◽  
Drug Substance ◽  
Design Parameters ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Chromatographic Methods ◽  
Hptlc Method

Abstract Two robust and selective stability-indicating chromatographic methods were developed and validated for the determination of metolazone in drug substance and pharmaceutical dosage form in the presence of its degradation products. The HPLC method employed a Kromasil C18 (250 × 4.6,5 μm) column and a mobile phase of acetonitrile: 0.2% orthophosphoric acid (32:68 v/v) at a flow rate 2 mL/min and detection at 238 nm. The separation was performed in HPLC isocratic mode. The robustness of the suggested method was assessed using the Plackett–Burman design, parameters affecting system suitability were established and non-significant intervals for the significant parameters were considered. The HPTLC method employed Nano-SIL-20 UV254 HPTLC plates as adsorbent, ethyl acetate: toluene: acetic acid solution (4:4:0.5, v/v/v), as a developing solvent system and densitometric detection at 238 nm. Metolazone was exposed to different stress conditions, including acid and alkaline hydrolysis and oxidative and photolytic degradation. The main degradation products obtained have been characterized and interpreted based on LC-MS. The linearity of the suggested methods was proved in the concentration range of 20–75 μg/mL for the HPLC method and 100–900 ng/spot for the HPTLC method. The suggested methods were validated according to international conference on harmonization guidelines. These methods were successfully dedicated for the estimation of metolazone in drug substance and pharmaceutical dosage form in the presence of its degradation products. The results of the suggested methods were evaluated and compared statistically with results obtained by an official method without finding any significant difference.

RADIOIMMUNOASSAY OF GROWTH HORMONE IN HUMAN PLASMA

1972 ◽  
Vol 71 (4) ◽  
pp. 649-664 ◽  
Author(s):  
Kristian F. Hanssen
Keyword(s):  
Growth Hormone ◽  
Human Plasma ◽  
Coefficient Of Variation ◽  
Degradation Products ◽  
Peak Plasma ◽  
Gel Filtration ◽  
Tolerance Test ◽  
Precipitation Reaction ◽  
Insulin Tolerance

ABSTRACT The double antibody radio-immunoassay (pre-precipitation technique) for immunoreactive growth hormone (IRHGH) in human plasma has been evaluated on the basis of dilution and recovery experiments as well as by the investigation of accuracy and reproducibility. Given optimal conditions for the precipitation reaction, the method seems suitable for determination of plasma IRHGH. No cross-reaction between the precipitating antiserum and human gammaglobulin was demonstrated. Furthermore, by using an incubation period of 6 days for the reaction between 125I-HGH and the precipitated HGH antibodies, no serum factor influencing this reaction could be demonstrated. The results of the plasma IRHGH determinations were shown to be independent of the percentage of the radioactive degradation products present in the tracer HGH. The lower detection limit is better than 0.39 ng/ml. The cumulated within-assay coefficient of variation was between 4–7% and the cumulated between-assay coefficient of variation 10%. By using gel filtration, IRHGH in the plasma was shown to be nonhomogeneous when considering molecular weight. The normal fasting values in the ambulatory state was (Mean ± sd) ng/ml: Men 1.48 ± 0.33; women 3.83 ± 3.47. During the insulin tolerance test the mean peak plasma IRHGH was lower in children than in adults (0.02 > P > 0.01). It is suggested that this is due to the influence of sex steroids in adult subjects.

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