Analytical Method Development and Validation ...

Analytical Method Development and Validation for Estimation of Residual Solvents in Formulation Containing Anti Diabetic Drug Using “Gas Chromatography”

Author Name : Manisha Prakash Mugade, Vilas Jagannath Pise, Vasant Yashwant Lokhande, Pallavi Laxman Salve

ABSTRACT Residual solvents in pharmaceuticals are termed as organic Volatile Impurities. These are the chemicals that are used in the manufacture of drugs substance or excipients or use in the preparation of final formulation. Analysis of organic volatile impurities is of key importance for Active Pharmaceutical Ingredients (API). Most of the available method could be expensive and time consuming. Hence, the quantification of Residual solvents in Anti Diabetics drug Containing Sitagliptin, Glimepiride and Metformin HCL Tablet was established using a headspace gas chromatography (HSGC) coupled with a flame ionization detector (FID). Isopropyl alcohol (IPA) Dichloromethane (DCM) as residual solvents were determined in Anti Diabetics drug Containing Sitagliptin, Glimepiride and Metformin HCL Tablet. Class 1 are environmental hazardous & toxic to human; Class 2 are toxic to human & environmental hazardous when it is in appropriate limit it is less toxic and Class 3 are less toxic and less environment hazardous. when is Analysis was performed by headspace GC/FID method on Perkin Elmer Clarus 680 with HS Turbo matrix 40 System. The method parameter was validated by Precision, System precision, Method precision, Raggedness, Specificity, LOD & LOQ, Linearity, Accuracy, Range, Robustness was validated according to the Internation Conference on Harmonization (ICH) guidelines.