Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TERBINAFINE HCl IN FORMULATED PRODUCT USING REVERSE PHASE ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY (RP-UPLC)

Akansha Gupta* and Tapeesh Bharti and Salahuddin

ABSTRACT

Terbinafine HCl is an antifungal agent used for the treatment of mycosessince as oral as well as a topical pharmaceutical dosage form. The UPLC method developed and validated for determination of Terbinafine hydrochloride is rapid, simple, sensitive and accurate. The purpose of the method development is to work on green chemistry by reducing the use of solvent and run time. The method developed is speedy, high resolution, solvent consumption is low and low cost of analysis with respect to HPLC method. Waters Acquity UPLC BEH C18 column (2.1 × 30mm, 1.7μm) column was used as stationary phase using by using mobile phase i.e. ACN: H2O (50:50). Method was developed in gradient mode with 2.5 minutes runtime, at flow rate of 0.6 ml/minute. The UV detection wavelength selected for this method is 222nm. The method recovery was found to be 97.66% - 98.53%. The method developed on UPLC was validated with respect to linearity, specificity, accuracy, precision, ruggedness (reproducibility), robustness and stability. Hence it can be apply for routine analysis of Terbinafine HCl in bulk and pharmaceutical formulation.

Keywords: Terbinafine HCl, UPLC, Accuracy, Precision, Robustness.


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