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

Patel, Rajesh; Patel, Mrunali R.; Patel, Nilay M.

doi:10.1080/22297928.2019.1700158

Cited by 6 publications

(1 citation statement)

References 14 publications

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“…A Box–Behnken statistical screening method was used to validate the compositional parameters and to determine the quadratic effects of mobile phase composition, mobile phase volume, and duration of saturation on the Rf. Quadratic polynomial equations are developed from experimental design using the Design‐Expert software as shown in Equation (1) (Patel et al, 2019; Shrivastava et al, 2021).

Y = β 0 + β 1X1 + β 2X2 + β 3X3 + β 12 normalX 1 X2 + β 13 normalX 1 X3 + β 23 normalX 2 X3 + β 11 {X1}^{2} + β 22 {X2}^{2} + β 33 {X3}^{2}

Y is the response; β 0 is the intercept representing the average arithmetic mean of all quantitative results of 17 runs; β 1– β 33 are the regression coefficients; and X1, X2, and X3 are the coded values of the independent variables, where X1 is the mobile phase composition, X2 is the mobile phase volume, and X3 is the duration of saturation.…”

Section: Methodsmentioning

confidence: 99%

Box–Behnken design avenue for development and validation of high‐performance thin‐layer chromatography method for estimation of rutin in Hemidesmus indicus

Shrivastava

Daharwal

2021

Biomedical Chromatography

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The aim of this study was to determine the content of rutin in Hemidesmus indicus and to optimize the high‐performance thin‐layer chromatography method. The method was validated in compliance with the International Council for Harmonisation guidelines Q2 (R1) for parameters such as linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. A Box–Behnken design and response surface methodology has been used to investigate the impact of independent variables on the response. Three independent variables, mobile phase composition (% v/v), mobile phase volume (mL), and duration of saturation (min), were studied. Rutin was verified, and its content was determined using a validated high‐performance thin‐layer chromatography method with good linearity within the range of 200–1000 ng spot–1 with r2 = 0.9998 and correlation coefficient with calibration curve equation y = 0.0297x + 0.0001. The average percentage recovery values varied from 99.03 to 101.15 and 98.88 to 100.12%, respectively, for in‐house and marketed mother tincture). The peak area determination at three different concentration levels shows low values of percentage relative standard deviation (<2%) for inter‐day (0.04–0.06) and intra‐day (0.04–0.05) precision of rutin. The average content of rutin in extract and marketed mother tincture was 229 ± 0.57 and 210 ± 0.57 μg g–1. The proposed method was simple, precise, and accurate for the determination of rutin with frequent quality control assessment of H. indicus.

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