Method Development and Validation for Quantification of Residual Solvents in Atorvastatin Calcium Drug Substance by GC-HS Using Fid Detector

Rahul Kumar; Hari Darshan Singh; Harendra Singh; Rahul Dev; Anil Tyagi

doi:10.55544/jrasb.1.3.24

Authors

Dr. Rahul Kumar Mankind Research Centre, IMT Manesar, Gurugram (Haryana), INDIA.
Hari Darshan Singh Mankind Research Centre, IMT Manesar, Gurugram (Haryana), INDIA.
Harendra Singh Mankind Research Centre, IMT Manesar, Gurugram (Haryana), INDIA.
Rahul Dev Mankind Research Centre, IMT Manesar, Gurugram (Haryana), INDIA.
Dr. Anil Tyagi Mankind Research Centre, IMT Manesar, Gurugram (Haryana), INDIA.

DOI:

https://doi.org/10.55544/jrasb.1.3.24

Keywords:

Gas Chromatography with Head space (GC-HS), Guideline for Residual Solvents Q3C(R8), Method Validation, Atorvastatin Calcium drug substance

Abstract

A proficient GC-HS method was developed for quantification of THIRTEEN residual solvents in Atorvastatin Calcium drugs substance with flame ionization detector (FID) using column Rtx-624, (60m length X 0.25mm diameter) 1.4µm film thickness, Part No.: 10969, Make: Restek. Nitrogen is used as Carrier gas with Linear velocity of 27.7cm/se on Shimadzu /GC-2010 Plus/HS-20 instrument. The proposed method was validated for System suitability, Specificity, Linearity, LOD and LOQ determination, Recovery, Precision, Range and Robustness. All the parameters were found within the acceptable limits. Linearity of all thirteen residual solvents are in the range of LOQ to 150%. The established methodology was commercially useful, specific, accurate, precise and suitable for the analysis of Residual solvents in Atorvastatin Calcium drug substance.

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