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Ion-pair RP-HPLC method for the estimation of eberconazole nitrate in bulk form and in pharmaceutical dosage forms

Vamsi Krishna M., Dash R. N., Jalachandra Reddy B., Venugopal P., Sandeep P., Madhavi G.

Acta Chromatographica

2013

Vol. 25, no. 3

503--518

An isocratic ion-pair reversed phase high-performance liquid chromatography-ultraviolet (RP-HPLC-UV) method for analysis of eberconazole nitrate in bulk and in pharmaceutical dosage forms has been developed and validated. Best separation was achieved on Lichrospher C18 column (250 mm × 4.6 mm, 5 μm) using a mobile phase of 10 mM potassium dihydrogen phosphate containing 10 mM tetra-butyl ammonium hydroxide (pH adjusted to 2.8 with ortho phosphoric acid) and methanol (75:25, v/v) at a flow rate of 1.0 mL min-1. UV detection was performed at 220 nm. The method was validated for specificity, linearity, precision, accuracy, limit of detection, limit of quantification, robustness, and solution stability. The calibration plot was linear over the concentration range of 10–80 μg mL-1 (r2 = 0.999) and the limits of detection and quantification were 0.3 and 0.9 μg mL-1, respectively. Intra-day and inter-day precisions were 1.13% and 1.67%, respectively. Experimental design was employed to optimize the method. The method was successfully used for analysis of eberconazole nitrate in commercially available cream (Ebernet).

Development and validation of an RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms

Ravi S., Darwis Y, Khan N

Acta Chromatographica

2009

Vol. 21, no. 3

421--432

An isocratic RP-HPLC-UV method for analysis of sumatriptan succinate in pharmaceutical dosage forms has been developed and validated. Best separation was achieved on a Thermo Hypersil C4 column (250 mm × 4.6 mm, 5 µm) using a mobile phase of 20 mM potassium dihydrogen phosphate adjusted to pH 4.0 with orthophosphoric acid and acetonitrile (65:35, v/v) at a flow rate of 1.0 mL min -1. UV detection was performed at 227 nm. The method was validated for specificity, linearity, precision, accuracy, limit of quantification, limit of detection, robustness, and solution stability. The calibration plot was linear over the concentration range 25–600 ng mL -1 (r 2= 0.9998) and the limits of detection and quantification were 10 and 25 ng mL -1, respectively. Intra-day and inter-day precision and accuracy were between 1.25 and 2.95% and between −1.15 and 2.47%, respectively. The method was successfully used for analysis of sumatriptan succinate, in the presence of excipients, in orally disintegrating tablets prepared in our laboratory and in commercially available tablets (Imigran) and nasal spray (Suminat).