In Vitro Biopharmaceutical and Physicochemical Evaluation of Different Brands of Ciprofloxacin Marketed in Aden-Yemen

The current study conducted to evaluate the biopharmaceutical and physicochemical equivalence of the three available pharmaceutical dosage forms of ciprofloxacin (CIP) in the local markets (tablets, infusion and eye drops). Three brands for each dosage form were selected and coded as Tablets I, II, III; CIP infusion (Infusion I, II, III) and CIP eye drops (Eye drops I, II, III). Different in vitro quality control tests, physiochemical and determination of active ingredients contents were performed. All brands of tablets have a satisfactory result that complies with the pharmacopeia specification except the hardness of the tablets was more than the recommended value, and the salinity of Infusion II and III was lower than 0.9, the viscosity of the eye drops was lower than the specified value. Post-marketing surveillance is an essential issue to distinguish poor-quality medicines and must be routinely performed to weed out substandard and counterfeit medicine.

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DEVELOPMENT AND VALIDATION OF ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF FEBUXOSTAT FOR CONDUCTING IN-VITRO QUALITY CONTROL TESTS IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i9.25550 ◽

2018 ◽

Vol 11 (9) ◽

pp. 115

Author(s):

Jaspreet Kaur ◽

Daljit Kaur ◽

Sukhmeet Singh

Keyword(s):

Spectrophotometric Method ◽

Limit Of Detection ◽

Pharmaceutical Formulations ◽

Dosage Forms ◽

Pharmaceutical Dosage Forms ◽

Relative Standard ◽

Limit Of Quantitation ◽

Development And Validation

Objective: A simple, accurate, and selective ultraviolet-spectrophotometric method has been developed for the estimation of febuxostat in the bulk and pharmaceutical dosage forms.Method: The method was developed and validated according to International Conference on Harmonization (ICH Q2 R1) guidelines. The developed method was validated statistically with respect to linearity, range, precision, accuracy, ruggedness, limit of detection (LOD), limit of quantitation (LOQ), and recovery. Specificity of the method was demonstrated by applying different stressed conditions to drug samples such as acid hydrolysis, alkaline hydrolysis, oxidative, photolytic, and thermal degradation.Results: The study was conducted using phosphate buffer pH 6.8 and λmax was found to be 312 nm. Standard plot having a concentration range of 1–10 μg/ml showed a good linear relationship with R2=0.999. The LOD and LOQ were found to be 0.118 μg/ml and 0.595 μg/ml, respectively. Recovery and percentage relative standard deviations were found to be 100.157±0.332% and <2%, respectively.Conclusion: Proposed method was successfully applicable to the pharmaceutical formulations containing febuxostat. Thus, the developed method is found to be simple, sensitive, accurate, precise, reproducible, and economical for the determination of febuxostat in pharmaceutical dosage forms.

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IN VITRO ANTIMICROBIAL ACTIVITY EVALUATION FOR DIFFERENT PHARMACEUTICAL DOSAGE FORMS OF CIPROFLOXACIN IN ADEN-YEMEN

Electronic Journal of University of Aden for Basic and Applied Sciences ◽

10.47372/ejua-ba.2020.2.23 ◽

2020 ◽

Vol 1 (2) ◽

pp. 93-99

Author(s):

Wafa F. S. Badulla ◽

Yafea S. T. Al-Omary ◽

Khaled Saeed Ali

Keyword(s):

Staphylococcus Aureus ◽

Antimicrobial Activity ◽

Inhibition Zone ◽

Dosage Forms ◽

Diffusion Method ◽

Eye Drops ◽

Pharmaceutical Dosage Forms ◽

Low Concentration ◽

E Coli ◽

Post Marketing Surveillance

Ciprofloxacin (CIP) is classified as a second-generation fluoroquinolone structurally similar to nalidixic acid. It is a widely used antibiotic to treat different types of bacterial infections. The present study was carried out to evaluate the antimicrobial activity of three different dosage forms of CIP [tablets (Tab coded I, II, III), CIP infusion (Infusion coded I, II, III) and CIP eye drop (Eyedrop coded I, II, III)]. Three most commonly prescribed and dispensed brands for each dosage form were selected. All studied brands were within their shelf life. All brands examined by spectroscopy and the quantity of the active ingredients was with the permitted limits of British pharmacopeia (95-105%). The disk diffusion method was used to evaluate the antimicrobial activity of CIP against E. coli and Staphylococcus Aureus. The highest inhibition zone was at low concentration against E. coli, by Tab-II, Tab-I, and Tab-III tablets respectively. While in the case of infusion, the Infusion-III showed the highest inhibition zone, followed by Infusion-I and Infusion-II. In the case of Staphylococcus Aureus, all Tab I, II, and III have similar potency. At low concentration, Infusion II, III indicated similar while Infusion I had lower potency. However, all brands had slightly higher potency over the standard. All brands of eye drops showed nearly similar potencies against Staphylococcus Aureus with a slight superiority of Eyedrop-I over Eyedrop-II then Eyedrop-III in the highest concentration. All the brands of eye drops showed antimicrobial activity slightly lower than standard. Post-marketing surveillance is an essential issue to distinguish poor-quality medicines. The current study revealed that the marketed CIP pharmaceutical dosage forms showed reasonable antimicrobial activity except for the eyedrops dosage forms which showed slightly lower inhibition zone in comparison to standard

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SIMPLE LIQUID CHROMATOGRAPHY METHOD WITH UV DETECTION FOR DETERMINATION OF BROMAZEPAM IN SOLID PHARMACEUTICAL DOSAGE FORMS

Knowledge International Journal ◽

10.35120/kij31041045b ◽

2019 ◽

Vol 31 (4) ◽

pp. 1045-1050

Author(s):

Irena Brcina ◽

Marija Darkovska Serafimovska ◽

Tijana Serafimovska ◽

Trajan Balkanov ◽

Biljana Gjorgjeska

Keyword(s):

Retention Time ◽

Direct Determination ◽

Dosage Forms ◽

Hplc Method ◽

Uv Detection ◽

In Vitro Dissolution ◽

Dissolution Test ◽

Pharmaceutical Dosage Forms

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 simulates the 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.

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Development and Validation of a RP-HPLC Method for Simultaneous Determination of Levofloxacin and Moxifloxacin in Pharmaceutical Dosage Forms

Dhaka University Journal of Pharmaceutical Sciences ◽

10.3329/dujps.v12i2.17614 ◽

2014 ◽

Vol 12 (2) ◽

Author(s):

Farjahan Nur ◽

Asma Rahman ◽

Md. Zakir Sultan ◽

Md. Gias Uddin ◽

Mohammad A Rashid

Keyword(s):

Simultaneous Determination ◽

Dosage Forms ◽

Hplc Method ◽

Pharmaceutical Dosage Forms ◽

Rp Hplc ◽

Development And Validation

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Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2011.4.4.7 ◽

2012 ◽

Vol 4 (4) ◽

pp. 1563-1568

Author(s):

Sagar Suman Panda ◽

Ravi Kumar B V V ◽

D Patanaik

Keyword(s):

Spectrophotometric Method ◽

Absorption Maximum ◽

Dosage Form ◽

Dosage Forms ◽

Alendronate Sodium ◽

Colored Complex ◽

Pharmaceutical Dosage Forms ◽

Recovery Study ◽

Assay Conditions

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.

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Electroanalytical Methods for Determination of Calcium Channel Blockers

Current Analytical Chemistry ◽

10.2174/1573411014666180426165750 ◽

2019 ◽

Vol 15 (3) ◽

pp. 207-218 ◽

Cited By ~ 1

Author(s):

Fatma Ağın

Keyword(s):

Calcium Channel ◽

Calcium Channel Blockers ◽

Channel Blocker ◽

Heart Diseases ◽

Dosage Forms ◽

Channel Blockers ◽

Electroanalytical Methods ◽

Pharmaceutical Dosage Forms ◽

Ischemic Heart Diseases

Background:Calcium Channel Blockers (CCBs) are widely used in the treatment of cardiovascular and ischemic heart diseases in recent years. They treat arrhythmias by reducing cardiac cycle contraction and also benefit ischemic heart diseases. Electroanalytical methods are very powerful analytical methods used in the pharmaceutical industry because of the determination of therapeutic agents and/or their metabolites in clinical samples at extremely low concentrations (10-50 ng/ml). The purpose of this review is to gather electroanalytical methods used for the determination of calcium channel blocker drugs in pharmaceutical dosage forms and biological media selected mainly from current articles.Methods:This review mainly includes recent determination studies of calcium channel blockers by electroanalytical methods from pharmaceutical dosage forms and biological samples. The studies of calcium channel blockers electroanalytical determination in the literature were reviewed and interpreted.Results:There are a lot of studies on amlodipine and nifedipine, but the number of studies on benidipine, cilnidipine, felodipine, isradipine, lercanidipine, lacidipine, levamlodipine, manidipine, nicardipine, nilvadipine, nimodipine, nisoldipine, nitrendipine, diltiazem, and verapamil are limited in the literature. In these studies, DPV and SWV are the most used methods. The other methods were used less for the determination of calcium channel blocker drugs.Conclusion:Electroanalytical methods especially voltammetric methods supply reproducible and reliable results for the analysis of the analyte. These methods are simple, more sensitive, rapid and inexpensive compared to the usually used spectroscopic and chromatographic methods.

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