Optimization of TLC method for separation and determination of ziprasidone and its impurities

Abstract

A thin-layer chromatographic method for simultaneous determination of ziprasidone and its main impurities was developed and validated. Separation of the examined compounds was performed on chromatographic plates precoated with silica gel 60F 254 and using toluene-methanol-glacial acetic acid, 7.5:0.5:0.5 (v/v/v) as mobile phase. Ascending development mode was performed in the twin-trough chromatographic chamber, which was presaturated with mobile phase vapors for 15 min. The developed chromatographic plates were dried in air and densitometrically scanned at the wavelengths of 250 and 320 nm. Regression coefficient (r≥0.992), recovery (94.94-106.70%), limit of quantification of impurities (25 ng band -1 equivalent to the 0.14% impurity level), and robustness were validated and found satisfactory. The developed method is convenient for quantitative analysis and the purity screening of ziprasidone in pharmaceutical formulations.

Development of Analytical Quality by Design Compliant Chaotropic Chromatography Method for Ziprasidone and Its Five Impurities Determination

“…In addition, few other methods are described in the literature that involve the determination of the content of ZPS and its five impurities. Although the developed TLC densitometric method [ 6 ] for the simultaneous determination of ZPS and its five impurities is the simplest chromatographic separation technique, its insufficient sensitivity and the use of toluene as mobile phase limit its applicability. A sensitive and reproducible RP-HPLC gradient elution method was developed and validated for the determination of ZPS and its five impurities [ 7 ].…”

“…The methods available in the literature for the analysis of ZPS and its five impurities have a drawback that is mainly related to the complicated and time-consuming chromatographic analysis [ 4 , 5 ], the lack of sensitivity [ 6 ], the use of phosphate salt and trietylamine as mobile phase modifiers [ 7 ], which are not recommended because of their influence on the lifetime of the column and chromatographic system, or the use of equipment that is not easily accessible in routine drug quality control [ 9 ]. Moreover, the basic properties and significant polarity differences in these solutes pose additional challenges for their RP-HPLC separation and determination.…”

Influence of selected mobile phase properties on the TLC retention behavior of ziprasidone and its impurities

“…In our previous papers relating to the thin-layer chromatography, experimental design and quantitative structure-retention relationships analysis were applied for detailed investigation of the retention behavior of ziprasidone and its impurities, [11] while fast and simple TLC method was developed and applied for their determination. [12] In this study, the influence of selected mobile phase properties, such as Snyder polarity and Hansen total solubility, on the retention behavior of ziprasidone and its five impurities was systematically investigated. …”

Ultra‐performance liquid chromatography tandem mass spectrometry for the rapid, simultaneous analysis of ziprasidone and its impurities

“…In the literature there are no data about the quantitative determination of ziprasidone and investigated impurities in raw materials and pharmaceuticals by the UHPLC–MS/MS method. Quantification of ziprasidone has been performed by spectrophotometry (Srinubabu, Rani, & SeshagiriRao, ), high‐performance thin‐layer chromatography (Skibinski & Komsta, ), thin‐layer chromatography (Obradović, Filipić, Nikolić, Čarapić, & Agbaba, ), capillary electrophoresis (Farina, Kremser, Raggi, & Kenndler, ), and HPLC with the UV detection (Dhakane, Kotharkar, & Ubale, ; Prasanthi & Rao, ; Bansal et al, ). Determination of ziprasidone and its impurities was performed using HPLC‐UV but without providing relevant purity characteristics for all of the analytes (El‐Sherif, El‐Zeany, El‐Houssini, Rashed, & Aboul‐Enein, ; Singh et al, ).…”