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

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 UV SPECTROPHOTOMETRY METHOD DEVELOPMENT AND VALIDATION OF SULFADIAZINE AND TRIMETHOPRIM IN COMBINED DOSAGE FORM

2018 ◽  
Vol 10 (1) ◽  
pp. 103
Author(s):  
Ramakrishna Veni Pokala ◽  
Kusuma Kumari ◽  
Hari Babu Bollikola
Keyword(s):  
Present Method ◽  
Method Development ◽  
Rapid Determination ◽  
Uv Spectrophotometry ◽  
Control Analysis ◽  
Quality Control Analysis ◽  
Double Beam ◽  
Method Development And Validation ◽  
Development And Validation

Objective: A new, simple, sensitive and economical UV spectrophotometric method was developed for the simultaneous analysis of Sulfadiazine [SDA] and Trimethoprim [TMP] in pharmaceutical formulations.Methods: This UV method was developed with methanol as solvent. The wavelengths selected for analysis in the present method were 265 nm for TMP and 289 nm for SDA. Teccomp UV-2301 double beam UV/Vis spectrophotometer was used to carry out spectral analysis and the data was recorded by Hitachi software.Results: Linearity was found to be within the concentration range of 2-9 µg/ml TMP and 9.08-41 µg/ml of SDA. Accuracy of the method was determined by recovery studies. Percentage recovery was found to be 98.20-99.25 for TMP with a % RSD of 0.338, 0.506 and 0.510 for three spiked levels. % RSD was found to be 0.229 and 0.380; 0.212 and 0.328 for SDA, TMP in intra and inter-day precision respectively. The % RSD value in ruggedness was found to be 0.440 for SDA and 0.569 for TMP.Conclusion: The advantages of this method for analytical purposes lie in the rapid determination, its cost-effectiveness, easy preparation of the sample, good reproducibility. In addition to this, the present method can be recommended for simultaneous determination of SDA and TMP in routine quality control analysis in combined drug formulations.

Bioanalytical Method Development and Validation for the Determination of Vasopressin Receptor Antagonist Conivaptan in Mouse Plasma at NanoLevel and its Pharmacokinetic Application

2019 ◽  
Vol 15 (5) ◽  
pp. 591-598 ◽  
Author(s):  
Haitham Alrabiah ◽  
Ahmed Bakheit ◽  
Sabray Attia ◽  
Gamal A.E. Mostafa
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Vasopressin Receptor ◽  
Mouse Plasma ◽  
Precipitation Procedure ◽  
Validation Parameters ◽  
The Us ◽  
Method Development And Validation ◽  
Development And Validation

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure. Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm. Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range. Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.

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