Simple liquid chromatography method with UV detection for determination of Bromazepam in solid pharmaceutical dosage forms

Brcina, Irena and Darkovska-Serafimovska, Marija and Serafimovska, Tijana and Balkanov, Trajan and Gjorgjeska, Biljana (2019) Simple liquid chromatography method with UV detection for determination of Bromazepam in solid pharmaceutical dosage forms. Knowledge - International Journal, Scientific Papers. ISSN 2545-4439

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Bromazepam is a psychoactive drug belonging to class of benzodiazepines with well-known hypnotic and sedative effects. It acts on the central neural system as an inhibitor of the neurotransmitter gamma aminobutyric
acid. It is frequently prescribed for treatment of severe anxiety, to reduce tension, agitation and depression.
Dissolution testing (the process by which a solid solute enters in to a solution) is a requirement for all solid oral
dosage forms and is used in all phases of research and development for product release and stability testing. Tablet dissolution test is a standardized method for measuring the rate of drug release from a dosage form and it simulatesthe percentage of active substance that can be absorbed into the blood circulation. The direct determination of Bromazepam in pharmaceutical dosage forms using HPLC with UV detector to carry out dissolution test, have not yet been described. Development of HPLC method with UV detection for direct determination of in-vitro
dissolution test of Bromazepam tablets, which can be used in the same time as method for determination of assay of
Bromazepam in Bromazepam tablets, can make analytical procedure easier and quicker. A simple, selective, linear,
precise and accurate RP-HPLC method has been developed and validated for assay and in-vitro dissolution test of
Bromazepam tablets. The method was validated according to the guidelines set by the International Conference of
Harmonization for validation of analytical procedures. The chromatographic separation was carried out using
reversed phase HPLC LiChrospher RP Select B column (125 x 4.0 mm i.d.; 5μm) at temperature of 50oC. Mobile
phase was consisting of the mixture of methanol, acetonitrile and potassium dihydrogen phosphate buffer (pH 7.0, adjusted with 0.5M Potassium hydroxide), with the ratio of 45:5:50 (v/v/v) and flow rate of 1.0 ml/min. The
detection was carried out at 239 nm. System suitability tests were performed through evaluation of different
parameters (retention time, tailing factor, retention factor and selectivity) on freshly prepared standard solution of
bromazepam. The retention time of bromazepam in 0,1M HCl was 3.5 min. High percentage of recovery shows that
the method is free from the interferences from excipients in test samples. Linearity of response was calculated as a
ratio of peak areas of bromazepam vs. concentration in 0,1M HCl and spiked tablets in the concentration range of
0.0018 – 0.016 mgmL-1. The response was linear over the concentration range of 0.0018 – 0.016 mgmL-1 and
coefficient of correlation was greater than 0.99. Good linearity shows that the proposed method may be useful for
quickly and routinely determination of the percentage of dissolved bromazepam from bromazepam tablets and it can
be a method of choice for assay determination in the same time.

Item Type: Article
Subjects: Medical and Health Sciences > Health sciences
Divisions: Faculty of Medical Science
Depositing User: Marija Darkovska-Serafimovska
Date Deposited: 20 Jun 2019 07:27
Last Modified: 20 Jun 2019 07:27

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