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Two stability-indicating chromatographic methods for the determination of clotrimazole and its two acid induced degradation products, with dexamethasone acetate without prior separation. First method depends on RP-HPLC utilizing ODS-3 Inertsil C18 column. Mobile phase consists of acetonitrile:phosphate buffer (pH 6.0) in ratio (65:35, v/v) with flow rate 1.5 mL/min and UV-detection at 220 nm. Linearity range 1.0-75.0 μg/mL for clotrimazole and 2.0-75.0 μg/mL for dexamethasone with mean percentage recovery of 99.49 ± 1.10 for CLT and 99.60 ± 1.06 for DA. Second method depends on HP-TLC. Developing system is composed of chloroform:ethyl acetate in the ratio of (5:3.5, v/v), scanned at 220 nm. Linearity range 1.0-12.0 μg/band for clotrimazole and 1.0-20.0 μg/band for dexamethasone with mean R% of 99.33 ± 0.76 for clotrimazole and 99.77 ± 0.99 for dexamethasone. Conditions and parameters affecting the separation of the cited components without interference of the degradation products are tested and optimized. Suitability of the methods for quantization of the drugs concentrations is proven by validation as instructed from the ICH. Validation results and statistical treatment of the data demonstrate reliability of these methods. Kinetics of acid degradation process of clotrimazole are investigated by the proposed HPLC method and the order rate constant, half life and shelf life are computed.
This article was published in the following journal.
Name: Journal of chromatographic science
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The main objective of the study is to analyze the structural behaviour and fungicidal activity of clotrimazole by experimental and theoretical spectroscopic techniques. Its computational results are c...
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A Comparative Clinical Trial to Evaluate the Safety and Clinical Equivalence of Clotrimazole Troche/Lozenges USP, 10mg (Unique Pharmaceutical Laboratories, India) With Clotrimazole Troche 10mg (Roxane Laboratories Inc., USA) in Subjects With Oropharyngeal
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This is a multi-center, randomized, prospective, active-controlled, double-blind, dose-escalation study comparing dose response of clinical efficacy, safety, local tolerability of three di...
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Measurable biological parameters that serve for drug development, safety and dosing (DRUG MONITORING).
Catalyzes the oxidation of catechol to 2-hydroxymuconate semialdehyde in the carbazole and BENZOATE degradation via HYDROXYLATION pathways. It also catalyzes the conversion of 3-methylcatechol to cis, cis-2-hydroxy-6-oxohept-2,4-dienoate in the TOLUENE and XYLENE degradation pathway. This enzyme was formerly characterized as EC 18.104.22.168.
A group of autosomal recessive lysosomal storage disorders marked by the accumulation of GANGLIOSIDES. They are caused by impaired enzymes or defective cofactors required for normal ganglioside degradation in the LYSOSOMES. Gangliosidoses are classified by the specific ganglioside accumulated in the defective degradation pathway.
Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery.
The presence of organisms, or any foreign material that makes a drug preparation impure.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...