2014
DOI: 10.3797/scipharm.1310-21
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Isolation, Identification, and Characterization of One Degradation Product in Ambroxol by HPLC-Hyphenated Techniques

Abstract: This study details the isolation, identification, and characterization of ambroxol’s unknown impurity. One unknown impurity of ambroxol was formed in the formulated drug under stress conditions [40°C /75% relative humidity (RH) for 6 months] with the relative retention time (RRT) 0.68 in RP-HPLC. The impurity was enriched by exposing it to heat and it was isolated by using preparative HPLC. The enriched impurity was purified and characterized using the following sophisticated techniques: 2D NMR (gDQ-COSY, gHSQ… Show more

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Cited by 7 publications
(5 citation statements)
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References 15 publications
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“…After incubation for 7 days, portions of the culture (10%, v/v) were transferred to fresh MSM supplemented with 200 mg/L malachite green and incubated for another 7 days. A third passage was carried out in MSM containing 300 mg/L malachite green 26 . The sludge sample was designated as JWY, and the three generations of enrichment cultures were designated as JW1, JW2, and JW3.…”
Section: Methodsmentioning
confidence: 99%
“…After incubation for 7 days, portions of the culture (10%, v/v) were transferred to fresh MSM supplemented with 200 mg/L malachite green and incubated for another 7 days. A third passage was carried out in MSM containing 300 mg/L malachite green 26 . The sludge sample was designated as JWY, and the three generations of enrichment cultures were designated as JW1, JW2, and JW3.…”
Section: Methodsmentioning
confidence: 99%
“…After 3 days, the rapidly growing colonies were picked up and purified by repeated streaking method at 15 °C. 16 The nicosulfuron-degrading ability of the isolates was detected by a HPLC system (1260, Agilent, Santa Clara, CA) equipped with a Hypersil ODS2 C 18 (4.0 mm × 250 mm, 5 μm) reversed-phase column. The mobile phase consisted of acetonitrile/distilled water/ acetic acid (70/30/0.1 V/V/V), and the flow rate was 1.0 mL/min.…”
Section: ■ Materials and Methodsmentioning
confidence: 99%
“…Finally, the cultures were spread on MSM agar plates supplemented with 100 mg/L of nicosulfuron as the carbon source, and the plates were incubated at 15 °C. After 3 days, the rapidly growing colonies were picked up and purified by repeated streaking method at 15 °C . The nicosulfuron-degrading ability of the isolates was detected by a HPLC system (1260, Agilent, Santa Clara, CA) equipped with a Hypersil ODS2 C 18 (4.0 mm × 250 mm, 5 μm) reversed-phase column.…”
Section: Methodsmentioning
confidence: 99%
“…A large number of factors can affect the stability of a pharmaceutical product, that includes manufacturing process, stability of the molecule, storage conditions (temperature, exposure to light and humidity), as well as chemical reactions such as oxidation, reduction, hydrolysis, and racemization, which could occur after dilution of the drug before administration. The analyses carried out allowed not only the determination of the stability of the four drugs studied, but also the exclusion of degradation products, and impurities already known in literature for all tested drugs [12,15,16,21] (Figure 3).…”
Section: Resultsmentioning
confidence: 99%