RP-HPLC-PDAAnalyses of Tapentadol: Application of Experimental Design

The present study endeavors quality by design (QbD) assisted chromatographic method for the quantification of Efavirenz (ERZ) in bulk and tablet dosage form. Analytical QbD instigated with assignment of analytical target profile (ATP) and critical analytical attributes (CAAs). Risk assessment studies and factor screening studies facilitate to identify the critical method parameters (CMPs). Optimization was performed by employing 32 full factorial design using identified CMPs i.e., flow rate (X1) and pH of buffer (X2) at three different levels and evaluating selected CAAs i.e., retention time (Y1) and peak area (Y2). The individual and interactive influence of CMPs on CAAs were tested by statistical data and response surface plots. Analysis of variance (ANOVA) confirmed that method parameters are significant (P < 0.05). Chromatographic separation was achieved using methanol, 10 mM ammonium acetate buffer (70:30 v/v), pH adjusted at 3.1 with 0.05% ortho-phosphoric acid as a mobile phase at flow rate 1.0 mL/min, and a Nucleosil C18 (4.6 mm I.D. × 250 mm, 5 μm) column with UV detection at 247 nm. The method validation and subsequent stresses degradation studies according to ICH guidelines supported the method to be highly efficient for regular drug analysis and its degradation products. The proposed method was successfully demonstrated QbD based approach for the development of highly sensitive, reliable and suitable for routine analysis, and clinical applications.

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Optimization of HPLC Method by Using Central Composite Design for Simultaneous Estimation of Montelukast and Ebastine Dosage Form

Kumar Singh,

Verma,

Singh

et al. 2024

RJPT

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In this work, a novel method for the simultaneous estimate of Montelukast (MONT) and Ebastine (EBAS) in bulk drugs was developed using Central Composite Design (CCD).A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.A novel reverse-phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of Montelukast and Ebastine in bulk and formulation is what this work aims to create and test.With isocratic elution at a flow rate of 0.8 ml min-1 and a diode array detector operating at 241 nm, the separation was accomplished using methanol and 0.02M ammonium acetate buffer (pH 5.5 adjusted with diluted acetic acid) in the ratio of 80:20 v/v. Methanol composition (percent) (A), pH (B), and flow rate (C) were three independent variables that were examined.This method showed good linearity over a range of 2.5–25 μg/ml for both drugs. MONT limit of detection (LOD) and limit of quantitation (LOQ) were 0.298 and 0.905μg/ml while LOD and LOQ for EBAS were 0.594 and 1.80For both drugs, this technique demonstrated high linearity throughout a range of 2.5–25 μg/ml. Limits of detection (LOD) and quantitation (LOQ) for MONT were 0.298 and 0.905 μg/ml and 0.594 and 1.80 μg/ml for EBAS, respectively.The statistical data analysis determined that the Methanol composition and pH were the two independent variables that were most significant, with P 0.001. The suggested technique worked well and was optimised for the CCD model-based simultaneous estimate of both drugs.

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RP-HPLC-PDAAnalyses of Tapentadol: Application of Experimental Design

Cited by 3 publications

References 8 publications

Box-Behnken Experimental Design Aided Optimization of Stability Indicating HPTLC-Based Assay Method: Application in Pharmaceutical Dosage form Containing Model Drugs-Roxithromycin and Ambroxol Hydrochloride

Box-Behnken Experimental Design Aided Optimization of Stability Indicating HPTLC-Based Assay Method: Application in Pharmaceutical Dosage form Containing Model Drugs-Roxithromycin and Ambroxol Hydrochloride

Quantification and Validation of Stability-Indicating RP-HPLC Method for Efavirenz in Bulk and Tablet Dosage Form using Quality by Design (QbD): A Shifting Paradigm

Optimization of HPLC Method by Using Central Composite Design for Simultaneous Estimation of Montelukast and Ebastine Dosage Form

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