Simultaneous HPLC-Determination of Nortriptyline and Fluphenazine in One Minute Using Monolithic Stationary Phase

Abstract

& A simple, fast, robust, and accurate high-performance liquid chromatography (HPLC) method is described for simultaneous quantification of nortriptyline and fluphenazine in bulk powder and dosage forms. The chromatographic separation was carried out in less than one minute on Chromolith 1 Performance RP-18e column, which consists of monolithic rods of highly porous silica, using isocratic binary mobile phase of MeOH and 25 mM KH 2 PO 4 pH 4.5 in the ratio of 70: 30 at 5 mL min À1 flow rate and 40 C. The high porosity of stationary phase enables it to be used at high flow rates without problems concerning backpressure, these high flow rates in turn lead to strong reduction of analysis time. A diode array detector was used at 254 nm for detection. The method was validated for system suitability, linearity, precision, limits of detection and quantitation, specificity, and robustness. LOD were found to be 0.40 and 0.78 lg mL À1 for nortriptyline and fluphenazine, respectively. LOQ was 3.125 lg mL À1 for both analytes. Recovery values of this method were 98.50 and 98.00% for nortriptyline and fluphenazine, respectively, and reproducibility was within 2.36%. Robustness study was done for small changes in KH 2 PO 4 concentration and pH, temperature, flow rate, wavelength of detection, % of MeOH in mobile phase, and injection volume.

A validated liquid chromatographic method for the determination of fluphenazine hydrochloride in the presence of its degradation products: application to degradation kinetics

“…2 Several analytical methods have been reported for the determination of FLZ, either in pure form or pharmaceutical preparations and biological uids. These methods include spectrophotometry, 3 spectrouorimetry, 4-6 voltammetry, [7][8][9] High Performance Liquid Chromatography (HPLC), [10][11][12][13] Densitometric High Performance Thin Layer Chromatography (HPTLC), 14 capillary electrophoresis, 15 and chemiluminescence. 16 The British Pharmacopoeia (BP) 1 recommended a non-aqueous potentiometric method for the determination of FLZ using perchloric acid as a titrant; the LOD and LOQ were 4.5 and 6.3 mg mL À1 respectively.…”

Difference spectrophotometric method for the determination of Fluphenazine hydrochloride in tablets using peroxomonosulfate

“…) belongs to the piperazine class of phenothiazines [1], and is a typical antipsychotic drug used for the treatment of psychoses such as schizophrenia, manic phases of bipolar disorder, agitation, and dementia [2]. In addition, as a serotonin antagonist, this agent may inhibit lymphocyte and myeloma cell proliferation [3] spectrofluorimetry [6][7][8], voltammetry [9][10][11], high performance liquid chromatography (HPLC) [12][13][14][15][16][17], densitometric high performance thin layer chromatography (HPTLC) [18] capillary electrophoresis [19], and chemiluminescence [20].…”