QUALITYCONTROL OF CLOXACILLIN SOLD IN NIAMEY CITY BYTHIN LAYER CHROMATOGRAPHY

The objective of this study is to control the quality by Thin Layer ChromatographyCloxacillin used in Niamey cityafter carrying out a prospective survey on antibiotics commonly used in health centers and at the same time purchased from street vendors. This quality control aimed to investigate on eleven samples distributed as following as: five samples are from pharmacies five samples are from street vendors and one sample is the specialty which is used as reference to check their active ingredient. The different reagents used in this research are: Hydrochloric acid (HCl) 37 %, acetone, distilled water, ethyl acetate and acetic acid. All samples migrated in proposed diluent. This shows that all samples contain the active ingredient substance of cloxacillin. The percentage of the active ingredient were calculated as per protocol of Clarkes analysis of drugs and poisons in chemistry guidelines. It varies from 96.87 to 97.91for the pharmacies and 97.91 to 104.17for the street vendors. According to the results of the different frontal reportspercentage, all of themmeet the standards required by the WHO which is 90 to 110 %. This technique can be used for practical work or tutorial and laboratories where drug quality control mechanism is not often checked.

A Journey through the History of Drug Quality Control, from Greece to Costa Rica

This review describes the evolution and development of drug quality control throughout different times in history. A bibliographic research was conducted from the database JSTOR from the University of Costa Rica. This database contains information from academic journals and books from XIX to date. It covers different fields, such as anthropology, arts, biology, botany, health sciences, politics, pharmacy, history. Information was retrieved when the following words were present: pharmacy, quality, quality control, drugs, medicines, pharmacopoeia. In ancient history India, China, Greece, Egypt, Africa and America used different medicinal plants to cure or alleviate disease. In some of these regions, methods were developed to make medicinal preparations as safe and effective as possible. In ancient Greece, the need to have a complete knowledge of drugs to carry out their proper preparation and detect adulterations was emerging. In Europe there was a constant development in the field, from books containing simple lists of preparations and medicines to more complex pharmacopoeias that included quality of the medicines. In America, the United States Pharmacopoeia (USP) first appeared in 1820. In Costa Rica, the Specialized Laboratory for Drug Analysis, actually the Laboratory for Analysis and Pharmaceutical Consulting (LAYAFA), was created in 1965, to ensure the quality and safety of medicines registered and marketed in Costa Rica. Differences between regulations and quality standards across centuries and countries, and their impact on the commercialization of medicines, have promoted regulations to harmonize the requirements related to different activities of the processes of manufacture, registration and quality control of medicines.

Increase of constant weight rates of weighing bottles and evaporating dishes in a pharmacological experiment

Improving the constant weight rates of weighing bottles and evaporation dishes is beneficial to drug quality control. When different quantities of weighing bottles were dried under the same conditions, the greater the quantity is, the lower the constant weight rate will be. When quantities are controlled to be the same, weighing bottles that have been cooled for 50 minutes have higher constant weight rates than those cooled for half an hour. Without being affected by other factors, weighing bottles? constant weight rates are higher when the bottles are dried at the temperature of 180?C than 105?C. The rate increases when the bottled are dried for 8 hours instead of 5 hours. After soaking for 48 hours in the solution of 2% HNO3 + 6% HCl, the weighing bottles and evaporating dishes gain higher constant weight rates. Being more efficient, faster, economical and practical, this experiment has improved the method to increase constant weight rates of weighing bottles and evaporating dishes, without the need of auxiliary equipment, and thus increased the accuracy of drug weighing results.

Development and Validation of Dimeric Macrocyclic Tannin Assay Method in Dosage Forms

Introduction. Quantitative assessment of the active substance is necessary and perhaps the most significant part of the drug quality control. Validation of the analytical methods of quantitative assessment ensures their compliance with high requirements. The present study describes the development and validation of a spectrophotometry method for the quantitative evaluation of the active substance in the drug form of the national antitumor and antiangiogenic drug «Dimeric macrocyclic tannin (DMT) lyophilizate for solution for injection, 100 mg».Aim. The development and validation of the assay method for the standardization of «DMT lyophilizate for solution for injection, 100 mg».Materials and metods. The study used «DMT lyophilizate for solution for injection, 100 mg» and the active substance DMT. Method – spectrophotometry.Results and discussion. The methodof the quantitative assessment of the active substance in the DMT lyophilized drug by direct UV spectrophotometry was developed and the validation characteristics of the method were defined as a result of the study.Conclusion. The validation results showed that the assay method of DMT in the drug form has the appropriate accuracy, precision and linearity. The obtained results correspond to the approved criteria that allow the use of the developed methodology for evaluating the quality of the drug.

Microanalysis of Selected NSAIDs Using the Spectrophotometric Method

Non-steroidal anti-inflammatory drugs (NSAIDs) are the group of drugs most commonly used in medicine. They are available over the counter to treat fevers and pains of various origins. The clinical and pharmaceutical analysis of these drugs requires effective analytical procedures for drug quality control, pharmacodynamic and pharmacokinetic studies. This article presents the spectrophotometric method that was used to analyze selected drugs from the NSAID group. The conditions for the determination of selected coxibs and oxicams in the UV range with the use of microplates have been developed. The presented procedure has been validated in accordance with the requirements, guaranteeing reliable results. The obtained results give the basis for the conclusion that the method can be successfully used in the quality control of pharmaceutical preparations with a small amount of available sample.

THE METROLOGICAL ASPECTS OF DIOSMIN QUANTITATION IN PHARMACEUTICAL DOSAGE FORMS

Pharmaceutical dosage forms with diosmin in Russian Federation are allowed for medical using. Simple and informative methods of diosmin quantitation for drug quality control are needed. Background. The metrological parameters determination of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry. Methods. The study subject was Venarus®, Detralex® (tablets, suspension), Phlebopha®. Diosmin was quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 nm and 370 nm by the parameters of calibration was determined. Statistical data processing was carried out by methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA). Result. The range of diosmin quantitation by UVspectrophotometry was for wavelengths: 268 nm – 0,0001-0,001%, 370 nm – 0,0002-0,002%. The referencespecific absorbance values for diosmin at wavelengths of 268 nm and 370 nm in a sodium hydroxide solution 0,02M were 463,0±24,6 and 259,0±9,9 respectively. The means errors of diosmin concentrations in pharmaceutical dosage forms were for wavelength 268 nm – 8-12% and for 370 nm – 6-8%. On example Detralex® tablets analysis a prognostic calculation of the sample preparation error (extraction) for diosmin was performed. The sample preparation error was 8%. Conclusion. The values components of error for referencespecific absorbance value and sample preparation error for diosmin quantitation was determined (on example analysis Detralex® tablets). Calculation algorithms can be used to theoretically error estimate of sample preparation for other multicomponent samples in drug quality control.

The metrological parameters of diosmin quantitation in pharmaceutical dosage forms

Introduction. Pharmaceutical dosage forms with diosmin are allowed for medical use in Russian Federation. Simple and informative methods of diosmin quantitation for drug quality control are needed. Aim: determination of metrological parameters of diosmin quantitation in pharmaceutical dosage forms by UV-spectrophotometry. Matherials and methods. The study subjects Venarus, Detralex (tablets, suspension), Phlebopha. Diosmin were quantified by UV-spectrophotometry. The reference-specific absorbance values of diosmin at wavelengths of 268 and 370 nm by the parameters of calibration were determined. Statistical data processing was carried out by the methods of variation statistics, correlation, one-way analysis of variance using computer programs ChemMetr 1.0, ChemMetr Evaluation 1.0, Statistica 6.0 (Statsoft Inc., USA). Results. The range of diosmin quantitation by UV-spectrophotometry was revealed for the wavelength of 268 nm 0,0001-0,001%, 370 nm 0,0002-0,002%. The reference-specific absorbance values for diosmin at the wavelength of 268 and 370 nm in a sodium hydroxide solution 0,02M were 463,0 24,6 and 259,0 9,9 respectively. The mean errors of diosmin concentrations in pharmaceutical dosage forms were revealed for the wavelength of 268 nm 8-12% and for 370 nm 6-8%. Prognostic calculation of the sample preparation error (extraction) for diosmin was performed using the example of Detralex tablets. The sample preparation error was 8%. Conclusion. The values components of error for reference-specific absorbance value and sample preparation error for diosmin quantitation were determined (as exemplified by the study of Detralex tablets). Calculation algorithms can be used for error estimation of sample preparation for other multicomponent samples in drug quality control.

Development and Optimization of Solanum Lycocarpum Polyphenol Oxidase-Based Biosensor and Application towards Paracetamol Detection

Purpose: The development biosensing technologies capable of delivering fast and reliable analysis is a growing trend in drug quality control. Considering the emerging use of plant-based polyphenol oxidases (PPO) as biological component of electrochemical biosensors, this work reports the first Solanum lycocarpum PPO biosensor and its use in the pharmaceutical analysis of paracetamol in tablet formulations. Methods: The biosensor was optimized regarding fruit maturation (immature and mature-ripe), vegetal extract volume to be used in biosensor construction as well as optimal pH of electrochemical cell fluid. Results: Results evidenced that the extract which rendered the biosensor with best analytical performance was from immature fruits, and the biosensor produced using 100 µL of crude plant extract promoted better faradaic signal gathering. Moreover, when neutral pH media was used in the electrochemical cell, the biosensor showcased best faradaic signal output from the used redox probe (catechol), suggesting thence that the method presents high sensibility for phenolic compounds detection. Furthermore, the biosensor was able to quantify paracetamol in a linear range from 50 to 300 μM, showcasing LoD and LoQ of 3 μM and 10 μM, respectively. Conclusion: after careful evaluation, this biosensor might be a low-cost alternative for conventional pharmaceutical quality control methods.