scholarly journals Analytical Method Development and Validation for Determination of Residual Solvent in Zopiclone Tablets by Headspace Gas Chromatography

2016 ◽  
Vol 12 (1) ◽  
pp. 95-103
Author(s):  
Vishal Shinde ◽  
Chetan Bhalgat ◽  
Suraj S. Padwal ◽  
Santosh Thakre ◽  
Jayvant Harlikar ◽  
...  
Author(s):  
Rutuja M. Sanap ◽  
Sarika R. Wavhale ◽  
Vaibhavi V. Kunjir ◽  
Rajkumar V. Shete

A simple, sensitive and accurate UV- spectrophotometric absorption correction method has been developed for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form. Analytical method development and validation plays important role in the discovery manufacture of pharmaceuticals and development. In this paper, absorption correction method is used for multi-component analysis. The wavelengths selected for the analysis were 311nm for Telmisartan, 228nm for Chlorthalidone and 253nm for Amlodipine. Beer’s law obeyed the concentration range of 2-10 µg /ml, 2-10 µg /ml and 5-25 µg/ ml for Telmisartan, Amlodipine and Chlorthalidone. Methanol is used as a solvent. The accuracy of the method was assessed by recovery studies and was found between the range of 100% to 110% for Telmisartan, 85% to 110% for Amlodipine and 85% to 105% Chlorthalidone. The % RSD value was found to be less than 2. Thus, the method was simple, precise, economic, rapid, accurate and can be successfully applied for simultaneous determination of Telmisartan, Amlodipine and Chlorthalidone in combined tablet dosage form.


Author(s):  
A.C. Bhosale ◽  
V.C. Bhagat ◽  
V. V Kunjir ◽  
D.P. Kardile ◽  
R.V. Shete

Purpose: Analytical method development and validation for the quantitative determination of Prucalopride succinate in bulk and tablet formulation which plays major role in the development and manufacture of pharmaceuticals. Methods: In the present work a simple, rapid and reproducible UV-Visible Spectrophotometric method was developed and validated according to ICH guidelines. Results and Conclusions: The parameters linearity, specificity, precision, accuracy, and robustness were studied. The wavelength 243nm was selected for the estimation of drug using methanol as a solvent. The drug obeys Beer-lambert’s law over the concentration range 2-10μg/ml. The accuracy of the method was assessed by recovery studies and was found between 97.2- 98.3 %. The method was successfully applied for routine analysis of Prucalopride succinate in bulk and formulation.


INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (05) ◽  
pp. 32-35
Author(s):  
S. R Pattan ◽  
◽  
A.C Patni ◽  
R.A Mali ◽  
C.J. Patni ◽  
...  

The objective of this present work was to develop and validate analytical method for quantitative determination of perindopril erbumine and amlodipine besylate in bulk as well as in tablet formulation. The chromatographic separation of the two drugs was achieved on a Varian Microsorb-MV 100-5 C18 column (150×4.6mm, 10 μm). The mobile phase constituted of acetonitrile: buffer (65:35) and pH adjusted to 2.6 with ortho- phosphoric Acid was delivered at the flow rate 1mL/min. Detection was performed at 210 nm. Separation was completed within 6 min calibration curves were linear with correlation coefficient between 0.99 to 1.0 over the concentration range of 2.5 to 15 µg/mL of perindopril erbumine and 10 to 60 µg/mL of amlodipine besylate The relative standard deviation (R.S.D.) was found <2.3%. The proposed method is precise, accurate, selective and rapid for the simultaneous determination of perindopril erbumine and amlodipine besylate.


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