Development and validation of analytical method for simultaneous estimation of Betamethasone dipropionate, Tolnaftate, Iodochlorhydroxyquin in pharmaceutical dosage form.

Abstract A simple, accurate and precise RP-HPLC method was developed for simultaneous estimation of Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin. EclipseC18 (250mm×4.6mm) 5µ (particle size) was used as stationary phase. The mobile phase used was KH2PO4 buffer of pH 6.3: Acetonitrile 30:70 V/V. The mobile phase was delivered at flow rate 1.5 ml/min. UV detection was set at 254nm. The retention time of Betamethasone dipropionate, tolnaftate and Iodochlorhydroxyquin was found to be 5.2 minutes, 9.8 and 7.2 minutes respectively. Linearity was observed over the concentration range of 3.9-9.1µg/ml, 60-140 µg/ml and 60-140 µg/ml for Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin respectively. The LOD was found to be 0.44 µg/ml, 6.49 µg/ml and 4.64µg/ml for Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin respectively. Whereas LOQ was found to be 1.34 µg/ml,19.67 µg/ml and 14.08 µg/ml for Betamethasone dipropionate ,Tolnaftate and Iodochlorhydroxyquin respectively Moreover, the % RSD for repeatability, inter and intraday precision was found to be less than 2%, which reveals that the method is precise. The % recovery was found to be 100.84% for betamethasone dipropionate, 101.11% for tolnaftate and for 100.53% Iodochlorhydroxyquin. However, the change in flow rate and mobile phase ratio also did not show any significant variance. Assay of the combined dosage form finalized the applicability of this method for simultaneous estimation of Betamethasone dipropionate, Tolnaftate and Iodochlorhydroxyquin in combined dosage form.

Keywords RP-HPLC, betamethasone dipropionate, tolnaftate, iodochlorhydroxyquin.

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Updated: January 20, 2024 — 8:56 am