Journal of Analytical, Bioanalytical and Separation Techniques
Method Validation of Simvastatin Tablets for Estimating Acetone, Ethanol, Isopropyl Alcohol, and Dichloromethane by Gas Chromatograph with Head Space
Scient Institute of pharmacy, Kanapuram, Ibrahimpatan, Telangana, India
Shivakanth, R.K., Scient Institute of pharmacy, Kanapuram, Ibrahimpatan, Telangana, India,
Shivakanth, R.K., et al. Method Validation of Simvastatin Tablets for Estimating Acetone, Ethanol, Isopropyl Alcohol, and Dichloromethane by Gas Chromatograph with Head Space. (2017) J Anal Bioanal Sep Tech 2(1): 1- 4.
Â© 2017 Shivakanth, R.K. This is an Open access article distributed under the terms of Creative
Commons Attribution 4.0 International License.
KeywordsSimvastatin, Gas chromatography, HMG Co-A, Residual solvents, DB- 624, ICH
â€ƒâ€ƒA simple Gas Chromatography-Head Space(GC-HS) method for the determination of residual solvents in simvastatin tablets using Nitrogen as the carrier gas at 1.3 mL/min with DB-624 (30 m X 0.32 mm ID X 1.8 Î¼m) as column using Flame Ionisation Detector(FID) as detector was developed. The developed method was validated and parameters were to be found within the limits of international conference on harmonization (ICH) guidelines. The retention time for residual solvents individually and in spiked standard solution was determined. The % RSD for six injections should
be NMT15%. The percentage recovery ranges from 80 - 120%. The correlation coefficient R2 â‰¥ 0.99. The limit of detection and limit of quantification was found to be specific. Precision, method precision and intermediate precision was found to be within the acceptance limit. Finally the sample was tested for the presence of residual solvents mainly Isopropyl alcohol was found.