Brchina, Irena and Gjorgjeska, Biljana (2018) Development and validation of HPLC method for in-vitro determination of dissolution of Bromazepam in tablets. Knowledge – International Journal, 23 (2). ISSN 2545-4439
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Abstract
Disorders that involve anxiety are the most common mental disturbances. Many of the anti-anxiety drugs also cause some sedation, so the same drug is often functioning clinically as both, anxiolytic and hypnotic agent. Benzodiazepines are the most widely used anxiolytic drugs. They have largely replaced barbiturates in the treatment of anxiety, because the benzodiazepines are safer and more effective.
The main objective of dissolution testing is to guarantee the quality of the pharmaceutical product, in order to prove consistency from one batch to another and that no important change occurs during the stability study change that could impact the efficacy of the pharmaceutical product. Purpose of the dissolution test is to demonstrate drug availability in the body for the desired serum level. Also, this research is focused on reducing the time needed to perform a number of analyzes in a short period of time and this contributes to a better economic benefit.
Tablet dissolution test is a standardized method for measuring the rate of drug release from a dosage form, (FDA, 1997). For dissolution medium 0.1 M HCl was chosen, in volume of 500 ml, at 37ºC, performed on ERWEKA DT 700, apparatus 2 (paddle), with 75 rpm for 45 minutes. An analytical method for Dissolution by using High Performance Liquid Chromatography technique was validated for content of Bromazepam and the validation was carried out on Shimadzu Nexera HPLC system.
To optimize chromatographic parameters several mobile phase compositions were tested in this method. A satisfactory separation, good peak symmetry and optimal retention time was obtained with mobile phase consisting a mixture of methanol, acetonitrile and potassium dihydrogen phosphate buffer (pH 7.0) in ratio of 45:5:50 (v/v/v) that was set at flow rate of 1.0 ml/min was found to be optimum and further optimized by adjusting pH 7.0 by adding KOH 0.5M. A LiChrospher RP Select B column (125 × 4.0 mm, 5μm) is used as stationary phase with temperature of column oven, 50ºC.
The method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness, solution stability and filter paper compatibility. All results of validation parameters meet the limits of ICH guidelines (ICH Q2, 2005).
The proposed method is simple, rapid, accurate, precise, and specific without interference of excipients. Its chromatographic run time of 3.50 min and 3.39 min allows the analysis of a large number of samples in short period of time. Therefore, it is suitable for the routine analysis of Bromazepam in pharmaceutical dosage forms. So it could be used for the rapid and reliable determination of Bromazepam in tablet formulations.
| Item Type: | Article |
|---|---|
| Subjects: | Medical and Health Sciences > Basic medicine Natural sciences > Chemical sciences Medical and Health Sciences > Health sciences Medical and Health Sciences > Other medical sciences |
| Divisions: | Faculty of Medical Science |
| Depositing User: | Biljana Gorgeska |
| Date Deposited: | 18 Jun 2018 10:29 |
| Last Modified: | 18 Jun 2018 10:29 |
| URI: | https://eprints.ugd.edu.mk/id/eprint/20071 |
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