scholarly journals Suitability System of Microbiological Method for Nystatin Potency Determination in the Routine Analysis Using Agar Diffusion Method

2021 ◽  
Vol 3 (4) ◽  
pp. 302-315
Author(s):  
Dalia Essam Eissa ◽  
Engy Refaat Rashed ◽  
Mostafa Essam Eissa
Keyword(s):  
Dosage Form ◽  
Parallel Line ◽  
The United States ◽  
Inhibitory Effect ◽  
Raw Material ◽  
Diffusion Method ◽  
Suitability Analysis ◽  
Time Saving ◽  
Pharmaceutical Dosage Form ◽  
Agar Diffusion

Nystatin is a polyene macrolide antifungal active which is used for the treatment of candidiasis and obtained from some species of Streptomycesbacteria. The present work describes the statistical suitability analysis for regular monitoring of the agar diffusion bioassay in a simple, inexpensive and time-saving process before potency determination. A balanced (symmetrical) two-dose parallel line assay model was applied using the agar well diffusion method for quantification of Nystatin in raw material and finished medicinal dosage form. The routine inspection methodology yielded good results and included calculations by the linear parallel model and by means of regression analysis and verified using analysis of variance (ANOVA). The assay is based on the inhibitory effect of Nystatin upon a standard strain as described in the United States Pharmacopeia (USP). The results of the post validation regular assays were treated statistically by ANOVA and the deviations (expressed as average ± standard deviation) from both raw and column totals were 0.702 ± 0.476 and 0.865 ± 0.468, respectively. The mean value of the variance ratio for regression and parallelism squares were 534.349 ± 212.546 and 0.596 ± 0.345, respectively. The study of Nystatin's ongoing analysis showed that the microbiological assay design is satisfactory with respect to the limiting values for the determination of the potency. The established balanced parallel line assay is reasonably stable and suitable and can be used for the regular drug analysis in routine quality control testing and the quantitation of Nystatin in pharmaceutical dosage form and raw material. Doi: 10.28991/SciMedJ-2021-0304-2 Full Text: PDF

scholarly journals Development of agar diffusion method for dosage of gramicidin

2011 ◽  
Vol 47 (3) ◽  
pp. 564-572
Author(s):  
Ana Gabriela Reis Solano ◽  
Larissa de Melo Campos Sousa Pereira ◽  
Míriam de Fátima Vianna Leonel ◽  
Elzíria de Aguiar Nunan
Keyword(s):  
Limit Of Detection ◽  
Pharmaceutical Preparations ◽  
Parallel Line ◽  
Raw Material ◽  
Diffusion Method ◽  
Tolerance Interval ◽  
Standard Curve ◽  
Agar Diffusion ◽  
Relative Standard ◽  
Agar Diffusion Method

Gramicidin, an antimicrobial peptide active against Gram positive bacteria, is commonly used in pharmaceutical preparations for topical use. Considering that only the turbidimetric method has been described in the literature, the present study sought to develop and validate an agar diffusion method for the dosage of gramicidin. The method was developed and validated using the Kocuria rhizophila ATCC 9341 as a test microorganism. Two designs were used: a 3x3 parallel-line model, and a 5x1 standard curve. The validation demonstrated that the method follows the linear model (r²= 0.994), presenting a significant regression between the zone diameter of growth inhibition and the logarithm of the concentration within the range of 5 to 25.3 µg/mL. The results obtained for both designs were precise, having a relative standard deviation (R.S.D.) for intra-day precision of 0.81 for the 3x3 assay and 1.90 for the 5x1 assay. For the inter-day precision, the R.S.D. was 1.35 for the 3x3 and 2.64 for the 5x1. The accuracy was verified and results confirmed to be accurate, having a tolerance interval of 95%, which lay within permitted limits and appropriate trueness. In addition, the method was considered selective, with limit of detection and upper and lower limits of quantification of 2.00, 5.00 and 25.3 µg/mL, respectively. No difference in precision between the designs used in the agar diffusion method was evident (p>0.05). The method proved to be appropriate for the microbiological dosage of the raw material gramicidin.

Significance of In-Vitro and In-Vivo Correlation in Drug Delivery System

2018 ◽  
Vol 4 (4) ◽  
pp. 523-531
Author(s):  
Hina Mumtaz ◽  
Muhammad Asim Farooq ◽  
Zainab Batool ◽  
Anam Ahsan ◽  
Ashikujaman Syed
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Preparations ◽  
Pharmacokinetic Profile ◽  
In Vitro Dissolution ◽  
Time Saving ◽  
Pharmaceutical Dosage Form ◽  
Short Period ◽  
Form Development

The main purpose of development pharmaceutical dosage form is to find out the in vivo and in vitro behavior of dosage form. This challenge is overcome by implementation of in-vivo and in-vitro correlation. Application of this technique is economical and time saving in dosage form development. It shortens the period of development dosage form as well as improves product quality. IVIVC reduce the experimental study on human because IVIVC involves the in vivo relevant media utilization in vitro specifications. The key goal of IVIVC is to serve as alternate for in vivo bioavailability studies and serve as justification for bio waivers. IVIVC follows the specifications and relevant quality control parameters that lead to improvement in pharmaceutical dosage form development in short period of time. Recently in-vivo in-vitro correlation (IVIVC) has found application to predict the pharmacokinetic behaviour of pharmaceutical preparations. It has emerged as a reliable tool to find the mode of absorption of several dosage forms. It is used to correlate the in-vitro dissolution with in vivo pharmacokinetic profile. IVIVC made use to predict the bioavailability of the drug of particular dosage form. IVIVC is satisfactory for the therapeutic release profile specifications of the formulation. IVIVC model has capability to predict plasma drug concentration from in vitro dissolution media.

scholarly journals Development and validation of a microbiological assay for determination of chlorhexidine digluconate in aqueous solution

2013 ◽  
Vol 49 (2) ◽  
pp. 351-358 ◽  
Author(s):  
Flávia Angélica Másquio Fiorentino ◽  
Marcos Antonio Corrêa ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Aqueous Solution ◽  
Pharmaceutical Formulations ◽  
Parallel Line ◽  
Inhibitory Effect ◽  
Microbiological Assay ◽  
Diffusion Method ◽  
Chlorhexidine Digluconate ◽  
Relative Standard ◽  
Pharmaceutical Industries ◽  
Development And Validation

Chlorhexidine (CHX) is a broad-spectrum antiseptic that is used in many topical pharmaceutical formulations. Because there is no official microbiological assay reported in the literature that is used to quantify CHX, this paper reports the development and validation of a simple, sensitive, accurate and reproducible agar diffusion method for the dosage of chlorhexidine digluconate (CHX-D) in an aqueous solution. The assay is based on the inhibitory effect of CHX-D upon the strain of Staphylococcus aureus ATCC 25923, which is used as the test microorganism. The design 3x3 parallel-line model was used. The results were treated statistically by analysis of variance (ANOVA), and they were excellent in terms of linearity (r = 0.9999), presenting a significant regression between the zone diameter of growth inhibition and the logarithm of the concentration within the range of 0.5 to 4.5%. The results obtained were precise, having relative standard deviations (RSD) for intra-day and inter-day precision of 2.03% and 2.94%, respectively. The accuracy was 99.03%. The method proved to be very useful and appropriate for the microbiological dosage of CHX-D in pharmaceutical formulations; it might also be used for routine drug analysis during quality control in pharmaceutical industries.

scholarly journals MICROBIOLOGICAL ASSAY FOR THE DETERMINATION OF CEFPIROME IN RAW MATERIAL AND INJECTABLE PREPARATION

2018 ◽  
Vol 2 (1) ◽  
pp. 29-35
Author(s):  
Tércio Paschke Oppe ◽  
Julia Menegola ◽  
Elfrides E.S. Schapoval
Keyword(s):  
Bacterial Infections ◽  
Degradation Products ◽  
Generation Cephalosporin ◽  
Inhibitory Effect ◽  
Drug Analysis ◽  
Stability Study ◽  
Microbiological Assay ◽  
Raw Material ◽  
Fourth Generation ◽  
Pharmaceutical Dosage Form

Cefpirome is a fourth-generation cephalosporin active against a broad spectrum of gram-negative and gram-positive bacterial infections. The present work describe the development and validation of a simple, sensitive and specific agar diffusion bioassay applying cylinder-plate method for quantification of cefpirome in raw material and powder for injectable preparation. The validation method yielded good results and included linearity, precision, accuracy and specificity. The assay is based on the inhibitory effect of cefpirome upon the strain of Kocuria rizophila ATCC 9341 as the test microorganism. The result of assay were treated statistically by ANOVA and the response graphs for standard and sample solutions were linear (r = 0.9948) in the range of 0.3 – 1.2 µg mL-1, precise (intra-assay: RSD = 0.11; inter-assay: RSD = 0.18) and accurate (mean recovery value = 99.41%). A preliminary stability study of cefpirome showed that the microbiological assay is specific for the determination cefpirome in the presence of its degradation products. The proposed microbiological method allows the quantitation of cefpirome in pharmaceutical dosage form and raw material and can be used for the drug analysis in routine quality control.

scholarly journals A Validated RP-HPLC Method for the Determination of Diltiazem in Raw Material and Pharmaceutical Dosage Form

2018 ◽  
Vol 10 (6) ◽  
Author(s):  
B M S Kumar ◽  
B. Rajkamal ◽  
B. Chandramowli
Keyword(s):  
Quantitative Analysis ◽  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Raw Material ◽  
Array Detector ◽  
Detector Response ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

The objective of this work is to develop and validate a reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative analysis of Diltiazem in bulk and pharmaceutical dosage form. Chromatographic analyses were performed on RP C-18 column with a mobile phase consisting of 0.01M ammonium acetate in water, methanol and acetonitrile in the ratio 700:240:60 at a flow rate of 1 mL/min. The Diltiazem was detected and quantitated using a photodiode array detector at a wavelength of 295 nm with a retention time of 11.57 min. The detector response was linear in the concentration of 20-60μg/ml, the respective linear regression equation being Y=3000181x+356238.2. The limit of detection and limit of quantification were 0.5μg/ml and 0.15μg/ml respectively. The assay of Diltiazem in bulk was found to be 99.85%. From the recovery studies it was found that about 101% on average of Diltiazem was recovered which indicates high accuracy of the method. The method was validated by determining its accuracy, precision and system suitability. The method fulfilled the requirements for reliability and feasibility for application to the quantitative analysis of Diltiazem in bulk and pharmaceutical dosage form.

Soil fungistasis with respect to pH and profile

1969 ◽  
Vol 15 (11) ◽  
pp. 1273-1279 ◽  
Author(s):  
H. Schüepp ◽  
E. Frei
Keyword(s):  
Soil Ph ◽  
Inhibitory Effect ◽  
Soil Samples ◽  
Diffusion Method ◽  
Germination Test ◽  
Agar Diffusion ◽  
Fungistatic Activity ◽  
Soil Fungistasis ◽  
Agar Diffusion Method ◽  
Different Soils

Soil fungistatic activity was determined in different soils using the sterile cellophane–agar diffusion method. Comparing 35 soil samples from eight profiles, the inhibitory effect on Trichoderma koningi was found to increase with increasing soil pH irrespective of the depth at which the soil samples were taken.The fungistatic principle of seven soils was compared using 24 test fungi. Nearly all fungi affected by soil fungistasis were more strongly inhibited with increasing soil alkalinity.Susceptibility of some fungi to the fungistatic principle varied considerably with the age of the cultures from which the spores were collected. Inhibition of germination was significantly dependent on the length of preactivation of the agar discs over the soil. In some instances the inhibitory effect was considerably reduced if the agar discs were removed onto glass for the germination test after preactivation on cellophane over soil.

Preliminary in Vitro Investigations on The Inhibitory Activity of The Original Dietary Supplement Oxidal® on Pathogenic Bacterial Strains

2020 ◽  
Vol 11 ◽  
pp. 37-43
Author(s):  
Prof. Teodora P. Popova ◽  
Toshka Petrova ◽  
Ignat Ignatov ◽  
Stoil Karadzhov
Keyword(s):  
Dietary Supplement ◽  
Broad Spectrum ◽  
Pathogenic Bacteria ◽  
Antimicrobial Agents ◽  
Clinical Effectiveness ◽  
Inhibitory Effect ◽  
Diffusion Method ◽  
Bacterial Strains ◽  
Microbial Strains

The antimicrobial action of the dietary supplement Oxidal® was tested using the classic Bauer and Kirby agar-gel diffusion method. Clinical and reference strains of Staphylococcus aureus and Escherichia coli were used in the studies. The tested dietary supplement showed a well-pronounced inhibitory effect against the microbial strains commensurable with that of the broad-spectrum chemotherapeutic agent Enrofloxacin and showed even higher activity than the broad spectrum antibiotic Thiamphenicol. The proven inhibitory effect of the tested dietary supplement against the examined pathogenic bacteria is in accordance with the established clinical effectiveness standards for antimicrobial agents.

Antibacterial Activity of Thujaoccidentalis,ThujaorientalisandChamaecyparisobtusa

2017 ◽  
Vol 8 (03) ◽  
Author(s):  
Kyoung- Sun Seo ◽  
Seong Woo Jin ◽  
Seongkyu Choi ◽  
Kyeong Won Yun
Keyword(s):  
Staphylococcus Aureus ◽  
Antibacterial Activity ◽  
Antibacterial Agent ◽  
Methanol Extract ◽  
The Other ◽  
Diffusion Method ◽  
E Coli ◽  
Agar Diffusion ◽  
Agar Diffusion Method ◽  
Crude Methanol Extract

The antibacterial activity of three Cupressaceae plants (Thujaoccidentalis,ThujaorientalisandChamaecyparisobtusa) was tested against three bacteria using the agar diffusion method. The ether and ethylacetate fraction of crude methanol extract from the three plants showed potent antibacterial activity against the tested microorganisms. The result showed that Staphylococcus aureus revealed the most sensitivity among the tested bacteria. Thujaoccidentalisether fraction and Thujaorientalis hexane fraction exhibited the highest antibacterial activity against Staphylococcus aureus. E. coli was shown the highest MIC values compared to the other two tested bacteria, which indicates the lowest antibacterial activity against the bacterium. This study promises an interesting future for designing a potentially active antibacterial agent from the three Cupressaceae plants.

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