AN OVERVIEW ON PHARMACOPOEIAS IN THE WORLD AND MONOGRAPH ELABORATION TECHNIQUES

Pharmacopoeias are official sources that contain national and international rules that must be complied with legally and scientifically regarding substances, materials, drugs, devices and methods used in pharmaceutical field and pharmaceutical production. The monographs are consisted of general titles such as definition, production, characters, identification, tests, assay, storage, labelling and impurities. The World Health Organization states that sixtyeight different pharmacopoeia continue to be used effectively in fifty six countries around the world. In this review information about national and international wold pharmacopoeias, structure and general content of pharmacopoeias, and monograph elaboration techniques are given.                      Peer Review History: Received 26 April 2020; Revised 25 May; Accepted 3 July, Available online 15 July 2020 Academic Editor: Dr. Nuray Arı, Ankara University, Turkiye, [email protected] UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 6.0/10 Average Peer review marks at publication stage: 8.0/10 Reviewer(s) detail: Dr. Mohammed Abdel-Wahab Sayed Abourehab, Umm Al-Qura University;  Makkah Al-Mukarramah, Saudi Arabia, [email protected] Heba M. Abd-El-Azim, Faculty of Pharmacy – Damanhour University, [email protected]

Validación de método cromatográfico por HPLC de la valoración e identificación del (1-(1β, 16α)-21-(acetiloxi)-11- hidroxi-2´-metil-5´H-pregna-1,4-dieno[17,16-d]oxazol-3,20- diona) en Deflazacort materia prima

Introduction. Deflazacort (DFZ) is a synthetic ozaxolinic glucocorticoid derived from prednisolone, it has anti-inflammatory properties and acts as an immunosuppressant, is the raw material used as the active ingredient of products marketed in pharmaceutical forms such as tablets and oral suspensions. Objective. Validate the methodology analytical by high performance liquid chromatography (HPLC), for the identification and assessment of (1-(1β,16α)-21-(acetyloxy)-11-hydroxy-2´-methyl-5´H-pregna-1,4 -dieno[17,16-d] oxazol-3,20-diona) in Deflazacort raw material under tropical climate conditions. Methodology.Using as mobile phase an isocratic mixture of methanol and water in a ratio of 80:20 with a flow of 1, 1mL/min, the column used was Luna® 5μm C8 100Ǻ 250 x 4.6mm, diode array detector at a wavelength of 245nm. Results. For linearity, a correlation coefficientR ≥ 0.999 was obtained, the coefficient of variation did not exceed the RS D of 2.0% in the repeatability of the system and in intermediate precision between analysts, an RSD value <3.0% was identified, in accuracy a recovery percentage of 98.9% was found.Conclusions. T he method is l inear, precise, exact, robust for a f low of 1.21mL/min a nd not for a flow of 0.99mL/min since it does not meet retention time. In the performance tests, Deflazacort showed low stability when exposed to degradation by basic hydrolysis with 1.0 N and 0.1 N NaOH solutions. The sample and the standard in solution showed to be stable at room temperature for two hours and refrigerated for three hours. Introducción. Deflazacort es un glucocorticoide ozaxolínico sintético derivado de la prednisolona, posee propiedades antiinflamatorias y actúa como inmunosupresor, es la materia prima utilizada como principio activo de productos comercializados en formas farmacéuticas como comprimidos y suspensiones orales. Objetivo. Validar la metodología analítica por cromatografía líquida de alta eficiencia, para la identificación y valoración del (1-(1β,16α)-21-(acetiloxi)-11-hydroxi-2´-metill-5´H-pregna-1,4-dieno[17,16-d] oxazol-3,20-diona) en Deflazacort materia prima en condiciones del clima tropical. Metodología. Utilizando como fase móvil una mezcla isocrática de metanol y agua en proporción de 80:20 con flujo de 1,1mL/min, la columna empleada fue Luna® de 5μm C8 100Ǻ 250 x 4,6mm, detector de matriz de diodos a una longitud de onda de 245nm. Resultados. Para la linealidad se obtuvo un coeficiente de correlación R ≥ 0,999, el coeficiente de variación no superó el RSD del 2,0% en la repetibilidad del sistema y en  recisión intermedia entre analistas se identificó un valor de RSD < 3,0%, en exactitud se encontró un porcentaje de recuperación de 98,9%. Conclusiones. El método es lineal, preciso, exacto, robusto para un flujo de 1,21mL/min y no para un flujo de 0,99mL/min ya que no cumple el parámetro de tiempo de retención. En las pruebas de desempeño el Deflazacort mostró una baja estabilidad cuando fue expuesto a degradación por hidrólisis básica con soluciones de hidróxido de sodio 1,0 N y 0,1 N. La muestra y el estándar en solución mostraron ser estables a temperatura ambiente por dos horas y refrigerados por tres horas.

Kształcenie muzyczne z perspektywy „Wiadomości Muzycznych” (1925-1926)

W Polsce w okresie międzywojennym ukazywało się przeszło sto czasopism muzycznych. Zostały one podzielone na kilka kategorii: przedmiotowo-metodyczne, muzyczną prasę społeczno- -kulturalną, czasopisma muzyczno-liturgiczne, regionalne periodyki muzyczne oraz pisma muzy- kologiczne i popularnonaukowe. W tej ostatniej grupie znalazły się stanowiące przedmiot niniej- szego artykułu „Wiadomości Muzyczne” (1925–1926), redagowane przez kolekcjonera muzyka- liów i publicystę Edwarda Wrockiego. Artykuł stanowi pierwszą próbę monograficznego opraco- wania tego periodyku, zarówno od strony formalno-wydawniczej, jak i zawartości treściowej. Zwrócono w nim jednak głównie uwagę na treści dotyczące kształcenia, dokształcania i doskona- lenia zawodowego muzyków oraz nauczycieli muzyki i śpiewu w różnych typach szkół (konserwa- toria i akademie muzyczne, szkoły średnie i powszechne, kursy).In Poland, over a hundred music magazines appeared in the interwar period. They were divided into several categories: subject and methodological, social and cultural music press, music and li- turgical magazines, regional music periodicals, as well as musicological and popular science mag- azines. The final group includes the subject of this article, “Wiadomości Muzyczne” (1925–1926), edited by the music collector and journalist Edward Wrocki. The article is the first attempt at a monograph elaboration of this periodical, both in terms of the formal and publishing aspects and its content. However, it focuses mainly on educational content, training and professional develop- ment of musicians and music and singing teachers in various types of schools (conservatories and music academies, primary and secondary schools, courses)

COMPARISON AND EVALUATION OF PHARMACOPOEIAL METHODS FOR THE ASSESSMENT OF POTENCY OF ANTIBIOTICS

The detection and assessment of potency of antibiotics are crucial for the pharmaceutics. The valid methods for microbiological assays in pharmacopoeias are mainly based on statistical comparison of the data obtained by measuring the cidal activity resulting from the treatment of the antibiotic active ingredient in the composition of the pharmaceutics with the target microorganism. However, it was seen that there is no validated microbiological method for some active ingredients. Due to microbiological assays are indispensable methods for determining the potency of some active ingredient groups, the calculation of the potency is performed logarithmically. In either turbidimetric or chromatographic methods, the statistical evaluation of the sample is compared with the standard reference material. Analysis data obtained by chromatographic and chemical methods are linear peak areas and spectrophotometer readings. In microbiological methods, the data obtained from the analyzes performed to determine the potency of antibiotics are the inhibition zone diameters or turbidimetric turbidity data. In this study, above-mentioned microbiological assays are compared in the context of the main pharmacopoeias EP, USP, CP, IP and BP, and evaluated in terms of the chromatographic method and classical microbiological method. It has been observed that chromatographic and chemical methods are not available to determine the potency of some pharmaceutical products containing antibiotics. The examinations made reveal the difficulty of analyzing some active ingredient groups according to chemical and chromatographic methods. For this reason, the importance of method validation studies is increasing in order to analyze active substances that do not have alternative analysis methods with microbiological and chemical methods. In this study, all validated microbiological methods were investigated, and it was aimed to determine alternative methods to chromatographic and chemical methods. It was concluded that the realization of new microbiological methods to be validated by evaluating the methods in all differences would facilitate the study.                    Peer Review History: Received: 18 May 2021; Revised: 15 June; Accepted: 28 June, Available online: 15 July 2021 Academic Editor: Dr. Asia Selman Abdullah,  Al-Razi university, Department of Pharmacy, Yemen, [email protected] Received file:                Reviewer's Comments: Average Peer review marks at initial stage: 6.5/10 Average Peer review marks at publication stage: 7.5/10 Reviewer(s) detail: Dr. Iman Muhammad Higazy, National Research Center, Egypt, [email protected] Dr. George Zhu, Tehran University of Medical Sciences, Tehran, Iran, [email protected] Similar Articles: AN OVERVIEW ON PHARMACOPOEIAS IN THE WORLD AND MONOGRAPH ELABORATION TECHNIQUE