Abstract
The current study deals with development and validation of a simple, fast and sensitive ultrafast liquid chromatographic method using the cardinal principles of analytical quality by design for estimation of paliperidone in extended release pharmaceutical dosage form. A Box-Behnken design was adopted for optimizing chromatographic conditions, especially the method robustness by selecting organic phase composition, mobile phase flow rate and strength of tetra butyl ammonium hydrogen sulfate solution as the factors, and evaluating their effect on the responses like, retention time and tailing factor. The chromatography was performed on a C-18 column (250 × 4.6 mm, 5 μm) using methanol: 10 mM tetra butyl ammonium hydrogen sulfate (95:5% v/v) as mobile phase at flow rate of 1.0 ml/min with photodiode array detection at 279 nm. Method validation studies revealed calibration curve with linearity of drug concentration ranging between 2 and 100 μg/ml. Values of accuracy were found to be well within the acceptance limit with mean percent recovery between 98.22 and 102.96%. Inter and intra-day precision showed percent RSD values were within the acceptance limits. Method sensitivity revealed that limit of detection and limit of quantitation as 0.5 μg/ml and 2 μg/ml, respectively. The system suitability analysis also yielded high degree of method robustness. Overall, the UFLC method was found suitable for determination of paliperidone in bulk and pharmaceutical dosage forms.
Highlights
The current study deals with development and validation of a simple, fast and sensitive ultrafast liquid chromatographic method using the cardinal principles of analytical quality by design for estimation of paliperidone in extended release pharmaceutical dosage form
Several analytical methods have been developed for estimation of paliperidone in pharmaceutical dosage forms and biological samples including spectrophotometric [2,3,4], high performance liquid chromatography(HPLC) [5,6,7,8,9,10,11,12], ultra performance liquid chromatography (UPLC) [13,14,15], high performance thin layer liquid chromatography(HPTLC) [16,17] and liquid chromatographymass spectrometry(LC-MS) [18,19] methods
A C-18 column was used for separation of the compound as it was found suitable based on chemical properties of analyte
Summary
The current study deals with development and validation of a simple, fast and sensitive ultrafast liquid chromatographic method using the cardinal principles of analytical quality by design for estimation of paliperidone in extended release pharmaceutical dosage form. Several analytical methods have been developed for estimation of paliperidone in pharmaceutical dosage forms and biological samples including spectrophotometric [2,3,4], high performance liquid chromatography(HPLC) [5,6,7,8,9,10,11,12], ultra performance liquid chromatography (UPLC) [13,14,15], high performance thin layer liquid chromatography(HPTLC) [16,17] and liquid chromatographymass spectrometry(LC-MS) [18,19] methods These reported chromatographic methods for estimation of paliperidone possess multiple drawbacks like traditional method development procedure, low sensitivity, complex mobile phase mixture, strict monitoring of critical method parameters like mobile phase flow rate, column temperature, flow gradient, maintenance of pH, etc. BBD has several advantages than compared with other statistical design approaches such as ability to optimize 33-Factorial designs, needs fewer numbers of total experiments, rotatibility and possess less physical constraints for experimentation [32] It can be effectively applied for navigating the design space for developing a robust UFLC method. The developed method was applied for estimation of paliperidone in extended release tablet dosage forms
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