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Highly selective separation of Mefloquine HCl and its diastereomer by using conventional RP-LC: A green analytical chemistry approach

. Jaya Raju Cheerla , Bhaskara Rao T and Sanath Kumar Goud P


Abstract

The concept of green analytical chemistry has been generating great interest in the field of pharmaceutical analysis for the separation of analytes on order to avoid use of organic solvents without compromising in chromatographic performance as well as to protect the environment. In the present research, principles of green chemistry were adopted to develop rapid, green, and robust stability indicating the RP-LC method for the separation of mefloquine hydrochloride and its diastereomer impurity by using mass-compatible mobile phases. The separation was achieved on Acquity UPLC BH C8 (100 x 2.1 mm),1.7µm column with an isocratic elution of 0.1% trifluoro acetic acid in water and ethanol in a ratio of 57:43% v/v as mobile phase at 0.2 mLmin-1 flow rate with UV detection at 220 nm with a column oven temperature of 50°C. The method was aimed to be eco-friendly and also an alternative to conventional chromatographic methods. The proposed method was validated as per the ICH Q2 (R1) guidelines and was found to be rapid, linear, precise, and accurate. The proposed validated method is deemed to be fit for the determination of diastereomer impurity in mefloquine hydrochloride bulk drugs (API) or finished dosage forms.

Key words: Mefloquine HCl, Diastereomer, Green analytical chromatography.

Abbreviations: Green Analytical Chemistry (GAC), Mefloquine HCl (MFQ), Reverse phase liquid chromatography (RP-LC), Ultra-high performance liquid chromatography (UHPLC), Liquid chromatography mass spectrometry (LCMS), Quadrupole Time of Flight (Q-TOF).

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