scholarly journals Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets

2019 ◽  
Vol 2019 ◽  
pp. 1-8
Author(s):  
Ivana Mitrevska ◽  
Tina Achkoska ◽  
Katerina Brezovska ◽  
Krume Toshev ◽  
Aneta Dimitrovska ◽  
...  
Keyword(s):  
Active Substance ◽  
Rotation Speed ◽  
Immediate Release ◽  
Class Iii ◽  
Dissolution Medium ◽  
Acceptance Criteria ◽  
Dissolution Method ◽  
Coated Tablet ◽  
Batch Testing ◽  
Development And Validation

The purpose of this study was to develop and validate a discriminative dissolution method for the metformin film-coated tablet with immediate release of the active substance that belongs to class III of the Biopharmaceutical Classification System (BCS). Different conditions such as type of dissolution medium, volume of dissolution medium, rotation speed, apparatus, and filter suitability were evaluated. The most discriminative release profile for the metformin film-coated tablet was accomplished by using Apparatus II (paddle) and 1000 mL of phosphate buffer pH 6.8 as the dissolution medium and maintained on 37 ± 0.5°C with a rotation speed of 75 rpm. The quantification of the released active substance was performed by UV/Vis spectrophotometry, at 232 nm. Acceptance criteria for not less than 75% (Q) of the labeled content for 45 minutes were set. The dissolution method was validated according to the current international guidelines using the following parameters: specificity, accuracy, precision, linearity, robustness, and stability of the solutions, found to be meeting the predetermined acceptance criteria. A developed dissolution method has discriminatory power to reflect the characteristics of the medicinal product and is able to distinguish any changes related to quantitative formulation and can be also applied for routine batch testing.

scholarly journals Development and validation of a dissolution method using HPLC for diclofenac potassium in oral suspension

2014 ◽  
Vol 50 (2) ◽  
pp. 423-429
Author(s):  
Alexandre Machado Rubim ◽  
Jaqueline Bandeira Rubenick ◽  
Luciane Varini Laporta ◽  
Clarice Madalena Bueno Rolim
Keyword(s):  
Rotation Speed ◽  
Oral Suspension ◽  
In Vitro Dissolution ◽  
Lauryl Sulfate ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Pharmaceutical Industries ◽  
Precision And Accuracy ◽  
Development And Validation

The present study describes the development and validation of an in vitro dissolution method for evaluation to release diclofenac potassium in oral suspension. The dissolution test was developed and validated according to international guidelines. Parameters like linearity, specificity, precision and accuracy were evaluated, as well as the influence of rotation speed and surfactant concentration on the medium. After selecting the best conditions, the method was validated using apparatus 2 (paddle), 50-rpm rotation speed, 900 mL of water with 0.3% sodium lauryl sulfate (SLS) as dissolution medium at 37.0 ± 0.5°C. Samples were analyzed using the HPLC-UV (PDA) method. The results obtained were satisfactory for the parameters evaluated. The method developed may be useful in routine quality control for pharmaceutical industries that produce oral suspensions containing diclofenac potassium.

scholarly journals Development and Validation of RP-HPLC Chromatographic Dissolution Method for the Simultaneous Estimation of Ramipril and Hydrochlorothiazide from Solid Dosage Formulation

2021 ◽  
pp. 203-217
Author(s):  
Prabhakar V. Raut ◽  
Sudhakar L. Padwal ◽  
Madhusudhan T. Bachute ◽  
Satish A. Polshettiwar
Keyword(s):  
Method Development ◽  
Theoretical Plate ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Rp Hplc ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Development And Validation

The present study describes the dissolution method development and validation of Ramipril and Hydrochlorothiazide in tablet dosage form by HPLC Method. A simple, rapid, selective, reproducible and isocratic reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated as per ICH guidelines. Analysis was performed on a Thermo, Sunniest C8 (150 mm x 4.6 mm, 5 µm) with the mobile phase consisting of mixing 500 mL of buffer solution and 500 mL of acetonitrile at a flow rate of 1.0mL/min. UV detection was performed at 210nm and the Run time for Ramipril and Hydrochlorothiazide were 10 minutes. The calibration curve was linear (correlation coefficient = 1.000) in the selected range for both analytes. The optimized dissolution conditions include the USP Type 1 (Basket) rotation rate of 100 rpm and 750 mL of 0.1 N Hydrochloric acid as dissolution medium, at 37.0 ± 0.5°C. The method was validated for precision, linearity, specificity, accuracy, limit of quantitation and ruggedness. The system suitability parameters, such as theoretical plate, tailing factor and relative standard deviation (RSD) between six standard replicates were well within the limits. The stability result shows that the drug is stable in the prescribed dissolution medium.

DISSOLUTION METHOD DEVELOPMENT AND VALIDATION OF TRAMADOL HYDROCHLORIDE CAPSULES

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (08) ◽  
pp. 47-50
Author(s):  
H Farheen ◽  
◽  
T Mamatha . ◽  
Z Yasmeen ◽  
Rao J. Venkateswara
Keyword(s):  
Method Development ◽  
Estimation Method ◽  
Dissolution Behavior ◽  
Official Method ◽  
Dissolution Medium ◽  
Tramadol Hydrochloride ◽  
Dissolution Method ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Usp Apparatus

A dissolution method was developed and validated for evaluation of the dissolution behavior of capsule dosage form of tramadol hydrochloride as there was no official method available. The UV spectrophotometric method developed was based on the direct estimation method using 271 nm as λmax of tramadol hydrochloride. The method was validated according to International Conference on Harmonisation (ICH) guidelines which include accuracy, precision, specificity, linearity, and analytical range. In addition, solubility and stability of the drug in dissolution medium i.e., 0.1 N HCl was studied. The established dissolution conditions were 900 mL dissolution medium at temperature 37 ± 0.5°C, using USP apparatus I at stirring rate of 100 rpm for 30 min. The corresponding dissolution profiles were constructed and all the selected brands showed more than 80% drug release with in 30 min. Thus, the proposed dissolution method can be applied successfully for the quality control of tramadol hydrochloride capsules.

scholarly journals Development and validation of an intrinsic dissolution method for nimodipine polymorphs

2014 ◽  
Vol 12 (5) ◽  
pp. 549-556 ◽  
Author(s):  
Manoela Riekes ◽  
Gislaine Kuminek ◽  
Gabriela Rauber ◽  
Silvia Cuffini ◽  
Hellen Stulzer
Keyword(s):  
Partial Solution ◽  
Alcoholic Solution ◽  
Test Validation ◽  
Rate Data ◽  
Dissolution Medium ◽  
Scanning Calorimetry ◽  
Intrinsic Dissolution ◽  
Dissolution Method ◽  
X Ray ◽  
Development And Validation

AbstractThe polymorphs of nimodipine, Modification I (Mod I), the metastable racemate, and Modification II (Mod II), the stable conglomerate, were evaluated by means of the intrinsic dissolution procedure. For this purpose, a hydro alcoholic solution (ethanol:water, 50:50, v/v) was selected as the dissolution medium, maintained at 37±0.5°C. Different rotation speeds were tested (50, 75 and 100 rpm) and the lower one was chosen for the test validation. Although the sample initially characterized as polymorph Mod I presented higher intrinsic dissolution rates in all the conditions tested, no statistical differences were noticed between the two polymorphs. This result can be attributed to the partial solution-mediated phase transformation from Mod I to Mod II, detected through X-ray powder diffraction and differential scanning calorimetry. Also, reliable intrinsic dissolution rate data were acquired for the polymorph Mod II. The dissolution method was validated, being considered stable, specific, linear, sensible, accurate and precise.

scholarly journals Dissolution Method Development and Validation for Estimation of Noscapine Tablets

2020 ◽  
Vol 10 (1-s) ◽  
pp. 159-164
Author(s):  
Jigar Vyas ◽  
Jaydip Solanaki ◽  
Kapil Daxini ◽  
Puja Vyas ◽  
Neha Pal
Keyword(s):  
Method Development ◽  
Uv Spectrophotometry ◽  
Dissolution Test ◽  
Dissolution Medium ◽  
Dissolution Method ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Usp Apparatus ◽  
Usp Apparatus 2

A dissolution method was developed and UV spectrophotometry was developed for the evaluation of the dissolution of tablets containing 15 mg Noscapine .The dissolution medium 0.1 N HCl was found suitable to ensure sink conditions. USP Apparatus 2, 900 mL dissolution medium 45 minutes and 100 RPM were fixed. Dissolution profiles were generated at 10, 15, 20,   30; 45 min. Dissolution samples were analyzed with UV spectrophotometer at 213 nm. The UV method for determination of tablet was developed and validated. The method presented linearity (R2 = 0.999) in the concentration range of 1–9 μg/mL. The recoveries were good, ranging from 97.18% to 101.45%. The intraday and Interday precision results were 0.54% and 0.78% RSD, respectively. The developed dissolution test is adequate for its purpose and can be applied for the quality control of tablets. Keywords: Dissolution test; Noscapine; Tablets; UV Spectrophotometry method

scholarly journals Development and validation of dissolution method for carvedilol compression-coated tablets

2011 ◽  
Vol 47 (4) ◽  
pp. 899-906 ◽  
Author(s):  
Ritesh Shah ◽  
Sachin Patel ◽  
Hetal Patel ◽  
Sonia Pandey ◽  
Shailesh Shah ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Phosphate Buffer ◽  
Immediate Release ◽  
The Body ◽  
Type I ◽  
Dissolution Method ◽  
Release Pattern ◽  
Ich Guidelines ◽  
Significant Difference ◽  
Development And Validation

The present study describes the development and validation of a dissolution method for carvedilol compression-coated tablets. Dissolution test was performed using a TDT-06T dissolution apparatus. Based on the physiological conditions of the body, 0.1N hydrochloric acid was used as dissolution medium and release was monitored for 2 hours to verify the immediate release pattern of the drug in acidic pH, followed by pH 6.8 in citric-phosphate buffer for 22 hours, to simulate a sustained release pattern in the intestine. Influences of rotation speed and surfactant concentration in medium were evaluated. Samples were analysed by validated UV visible spectrophotometric method at 286 nm. 1% sodium lauryl sulphate (SLS) was found to be optimum for improving carvedilol solubility in pH 6.8 citric-phosphate buffer. Analysis of variance showed no significant difference between the results obtained at 50 and 100 rpm. The discriminating dissolution method was successfully developed for carvedilol compression-coated tablets. The conditions that allowed dissolution determination were USP type I apparatus at 100 rpm, containing 1000 ml of 0.1N HCl for 2 hours, followed by pH 6.8 citric-phosphate buffer with 1% SLS for 22 hours at 37.0 ± 0.5 ºC. Samples were analysed by UV spectrophotometric method and validated as per ICH guidelines.

The Effect of Different Superdisintegrants and their Concentrations on the Dissolution of Topiramate Immediate Release Tablets

2009 ◽  
Vol 2 (2) ◽  
pp. 531-5366
Author(s):  
V A. Vamshi Priya ◽  
G. Chandra Sekhara Rao ◽  
D. Srinivas Reddy ◽  
V. Prabhakar Reddy
Keyword(s):  
Immediate Release ◽  
Drug Dissolution ◽  
Dissolution Profile ◽  
Dissolution Medium ◽  
Lactose Monohydrate ◽  
Sodium Starch Glycolate ◽  
Tablet Disintegration ◽  
Croscarmellose Sodium ◽  
Model Drug ◽  
Usp Apparatus

The purpose of this study was to investigate the efficiency of superdisintegrants: sodium starch glycolate, croscarmellose sodium and crospovidone in promoting tablet disintegration and drug dissolution of Topiramate immediate release tablets. The efficiency of superdisintegrants was tested, by considering four concentrations, viz., like 2%, 3%, 4% and 5% in the formulations. The dissolution was carried out in USP apparatus II at 50 rpm with distilled water as a dissolution medium. The dissolution rate of the model drug topiramate was found highly dependent on the tablet disintegration, on the particle size of the superdisintegrant, on the solubility of the drug and also on the type of superdisintegrant in the dissolution medium. There was no effect of the diluent (Lactose monohydrate) on the disintegration of different concentrations of superdisintegrants. These results suggest that, as determined by the f2 metric (similarity factor), the dissolution profile of the formulation containing 4% sodium starch glycolate and lactose monohydrate as a diluent was similar to that of a marketed product.

In vitro dissolution method fitted to in vivo absorption profile of rivaroxaban immediate-release tablets applying in silico data

2017 ◽  
Vol 44 (5) ◽  
pp. 723-728 ◽  
Author(s):  
Nathalie R. Wingert ◽  
Natália O. dos Santos ◽  
Sarah C. Campanharo ◽  
Elisa S. Simon ◽  
Nadia M. Volpato ◽  
...  
Keyword(s):  
In Silico ◽  
Immediate Release ◽  
In Vitro Dissolution ◽  
Absorption Profile ◽  
Dissolution Method ◽  
In Vivo Absorption

scholarly journals Quality assessment of nine paracetamol 500 mg tablet brands marketed in Saudi Arabia

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Reem AlSwayeh ◽  
Syed N. Alvi ◽  
Muhammad M. Hammami
Keyword(s):  
Saudi Arabia ◽  
Active Substance ◽  
Immediate Release ◽  
Water Medium ◽  
Breaking Force ◽  
Weight Variation ◽  
Percent Difference ◽  
Stage 1

Abstract Objective To evaluate in-vitro quality of paracetamol 500 mg tablet brands marketed in Saudi Arabia. Results Two reference (R1 and R2) and seven generic (G1-G7) brands were commercially available. Four brands were single-drug, containing paracetamol only (R1, G1-G3) and five contained additional active ingredients (R2, G4-G7). All brands were immediate-release. Weight variation (n = 20, range as percent difference from mean), active substance content (n = 20, mean (SD) as percent difference from label), breaking force (n = 10, mean (SD)), and friability (n = 20, as percent weight loss) ranged from 97 to 102%, 96.1% (2.9%) to 99.8% (1.1%), 9.9 (0.4) to 21.0 (0.9) kg, and 0.017% to 0.809%, respectively. Disintegration (water medium) time (n = 6, minute: second) ranged from 02:35–03:09 to 12:49–13:10. Dissolution (phosphate buffer, pH 5.8) profile showed a mean release at 30 min of 87% to 97% of label content, with seven brands passing stage-1 (≥ 85% for each of 6 test units) and two passing stage-2 (mean of 12 test units ≥ 85%) criteria. Despite statistically significant differences between R1 and R2 and some of their corresponding generic brands in active substance content, breaking force, and amount dissolved at 30 min, all nine brands met the pre-specified quality standards.

scholarly journals Developing methods to compare tablet formulations of atorvastatin

2012 ◽  
Vol 48 (4) ◽  
pp. 801-810 ◽  
Author(s):  
Marcelo Antonio de Oliveira ◽  
Caroline Dutra Lacerda ◽  
André Fazôlo Bonella
Keyword(s):  
Rotation Speed ◽  
Pharmaceutical Formulations ◽  
Generic Product ◽  
Dissolution Test ◽  
Dissolution Medium ◽  
Differential Dissolution ◽  
Tablet Formulations ◽  
Biopharmaceutical Classification System ◽  
Paddle Apparatus ◽  
The Ideal

Atorvastatin (ATV) is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm), detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v), flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q) in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.

Sign in / Sign up

Export Citation Format

Share Document