REPLACEMENT OF ACETONITRILE BY MIXTURES OF PROPYLENE CARBONATE AND METHANOL AS ORGANIC MODIFIER IN MOBILE PHASES FOR RPLC SEPARATION MECHANISM: APPLICATION TO THE ASSAY OF ALPRAZOLAM AND SERTRALINE IN COMBINED PHARMACEUTICAL FORMULATIONS

Abstract

Acetonitrile (ACN), methanol (MeOH), and tetrahydrofuran are the most commonly used organic solvents in RP-HPLC. The present work suggests how ACN in the mobile phase has been efficiently replaced by a new solvent mixture of propylene carbonate (PC) and MeOH in the ratio 60:40 in RP-HPLC method for simultaneous estimation of Alprazolam and Sertraline. Presently, PC is used as a solvent for synthetic polymers and as an electrochemical solvent. However, through the present study, it has been proved that it can also be used as a mobile phase component in RP-HPLC. PC has numerous advantages over ACN with respect to boiling point, flashpoint, biodegradability, clinical toxicity, and so forth. Two RP-HPLC methods have been developed and validated for the simultaneous estimation of Alprazolam and Sertraline in combined dosage forms using both ACN and Solvent-X (PC:Methanol; 60:40), respectively, as a mobile phase component. The two methods are then compared. It is observed that the method developed using Solvent-X is rapid, reproducible, and precise and meets the acceptance criteria for all parameters set by International Conference on Harmonization (ICH). Hence, it is speculated that Solvent-X can be used as a mobile phase component in RP-HPLC for routine qualitative and quantitative analysis in industries.

Keywords:

• acetonitrile
• alprazolam
• propylene carbonate
• RPLC
• sertraline
• Solvent-X

Notes

Note. Retention factors were calculated taking as void time indicator the injection peak; Peak symmetry was determined at 10% from peak height.