Development and validation of a discriminative dissolution medium for poorly soluble nutraceutical tetrahydrocurcumin

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.

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DISSOLUTION METHOD DEVELOPMENT AND VALIDATION OF TRAMADOL HYDROCHLORIDE CAPSULES

INDIAN DRUGS ◽

10.53879/id.50.08.p0047 ◽

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.

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Development and validation of an intrinsic dissolution method for nimodipine polymorphs

Open Chemistry ◽

10.2478/s11532-014-0511-9 ◽

2014 ◽

Vol 12 (5) ◽

pp. 549-556 ◽

Cited By ~ 5

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.

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An Investigation of the Release Properties of a Cationic Drug From a Hydrophobic Polyanhydride Matrix as a Function of Dissolution Medium

MRS Proceedings ◽

10.1557/proc-550-35 ◽

1998 ◽

Vol 550 ◽

Cited By ~ 1

Author(s):

E. J. Ginsburg ◽

T. D. Stultz ◽

D. A. Stephens ◽

D. Robinson ◽

Y. Tian ◽

...

Keyword(s):

Drug Delivery ◽

Drug Delivery System ◽

Anion Exchange ◽

Polymer Chain ◽

Delivery System ◽

In Vitro Release ◽

Dissolution Medium ◽

Poorly Soluble ◽

Vitro Release

AbstractThe dissolution of a drug delivery system consisting of gentamicin sulfate in a hydrophobic polyanhydride matrix has been examined. The in vitro release of gentamicin is a function of the composition of the dissolution medium, with slower release in pH 7.4 buffer than in unbuffered water. This is consistent with an anion exchange taking place under conditions in which carboxylate polymer chain-ends form a poorly soluble salt with gentamicin, and sulfate is released into solution. Results of additional experiments probing this model are digeussed.

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Dissolution Method Development and Validation for a Poorly Soluble Drug

10.26226/morressier.57d6b2bdd462b8028d88e4bd ◽

2016 ◽

Author(s):

Mingkun Fu

Keyword(s):

Method Development ◽

Dissolution Method ◽

Poorly Soluble ◽

Method Development And Validation ◽

Poorly Soluble Drug ◽

Development And Validation

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Development and validation of discriminatory dissolution procedure for poorly soluble glyburide

Asian Journal of Pharmaceutics ◽

10.4103/0973-8398.76744 ◽

2010 ◽

Vol 4 (4) ◽

pp. 205

Author(s):

SachinK Singh ◽

KK Srinivasan ◽

K Gowthamarajan ◽

GB Narayan

Keyword(s):

Poorly Soluble ◽

Development And Validation

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Dissolution Method Development and Validation for Estimation of Noscapine Tablets

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v10i1-s.3891 ◽

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

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

Brazilian Journal of Pharmaceutical Sciences ◽

10.1590/s1984-82502014000200022 ◽

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.

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

Journal of Analytical Methods in Chemistry ◽

10.1155/2019/4296321 ◽

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.

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