ICH Guidance in Practice: Validated Reversed-Phase HPLC Method for the Determination of Active Mangiferin from Extracts of Mangifera indica Linn

Gowda, Nagaraj; Kumar, Pradeep; Panghal, Surender; Rajshree, Mashru

doi:10.1093/chromsci/48.2.156

Cited by 10 publications

(4 citation statements)

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“…Analytical methods were reported for the determination of HCTZ in pharmaceutical formulations using spectrophotometry 15 and LC 16, 17. Many analytical methods to quantify the combination of HCTZ with other drugs include spectrophotometric methods 18–22, CE 23, 24, LC 25–34, LC and TLC 35, and LC and spectrophotometric methods 36–38. Recently, a stability‐indicating liquid chromatographic method was developed and validated by our research group for the determination of HCTZ and ALI in commercial tablet dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

Sangoi

Wrasse-Sangoi

Oliveira

et al. 2011

J of Separation Science

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A stability-indicating MEKC method was developed and validated for the simultaneous determination of aliskiren (ALI) and hydrochlorothiazide (HCTZ) in pharmaceutical formulations using ranitidine as an internal standard (IS). Optimal conditions for the separation of ALI, HCTZ and its major impurity chlorothiazide (CTZ), IS and degradation products were investigated. The method employed 47 mM Tris buffer and 47 mM anionic detergent SDS solution at pH 10.2 as the background electrolyte. MEKC method was performed on a fused-silica capillary (40 cm) at 28°C. Applied voltage was 26 kV (positive polarity) and photodiode array (PDA) detector was set at 217 nm. The method was validated in accordance with the ICH requirements. The method was linear over the concentration range of 5-100 and 60-1200 μg/mL for HCTZ and ALI, respectively (r(2) >0.9997). The stability-indicating capability of the method was established by enforced degradation studies combined with peak purity assessment using the PDA detection. Precision and accuracy evaluated by RSD were lower than 2%. The method proved to be robust by a fractional factorial design evaluation. The proposed MEKC method was successfully applied for the quantitative analysis of ALI and HCTZ both individually and in a combined dosage tablet formulation to support the quality control.

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Section: Introductionmentioning

confidence: 99%

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

Sangoi

Wrasse-Sangoi

Oliveira

et al. 2011

J of Separation Science

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“…The proposed method was validated according to ICH guidelines [26] including linearity, accuracy, precision, specificity, robustness, limit of detection (LOD) and limit of quantitation (LOQ). The linearity test solution was freshly prepared by diluting the stock standard solution with mobile phase.…”

Section: Methodsmentioning

confidence: 99%

A validated stability-indicating HPLC method for determination of brimonidine tartrate in BRI/PHEMA drug delivery systems

Sun

Zhang

Huang

2017

Chemistry Central Journal

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BackgroundA simple, rapid and accurate stability-indicating reverse phase high performance liquid chromatography (RP-HPLC) was developed and validated for the determination of brimonidine tartrate in brimonidine tartrate/poly(2-hydroxyethyl methacrylate) (BRI/PHEMA) drug delivery contact lenses and pharmaceutical formulations.ResultsOptimum chromatographic conditions for separating brimonidine tartrate from other impurities in the leaching liquor of BRI/PHEMA drug delivery contact lenses or pharmaceutical formulations have been achieved by using a Diamonsil C18 column (150 mm × 4.6 mm, 5 μm) as a stationary phase and a mixture solution of phosphate buffer (10 mM, pH3.5) containing 0.5% triethlamine and methanol (85:15, v/v) as a mobile phase at a flow rate of 1 mL/min. The theoretical plates for the brimonidine tartrate measurement were calculated to be 8360 when detection was performed at 246 nm using a diode array detector. The proposed method was validated in accordance with ICH guidelines with respect to linearity, accuracy, precision, robustness, specificity, limit of detection and quantitation. Regression analysis showed a good correlation (R2 > 0.999) for brimonidine tartrate in the concentration range of 0.01–50 μg/mL. The peak purity factor is ≥980 for the analyte after all types of stress tests, indicating an excellent separation of brimonidine tartrate peak from other impurities. The measurement course could be completed within 10 min, which was very quick, effective and convenient.ConclusionsOverall, the proposed stability-indicating method was suitable for routine quality control and drug analysis of brimonidine tartrate in BRI/PHEMA drug delivery contact lenses and other pharmaceutical formulations.

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“…Previous reports have demonstrated high‐performance liquid chromatography (HPLC) for estimation of Mgf in root powder of Salacia chinensis Linn. (Shastry, Haldankar, & Kadam, ), and in alcoholic extracts of Mangifera indica Linn (Dai, Gao, & Bi, ; Gowda, Kumar, Panghal, & Rajshree, ) in Chinese preparation. Determination of Mgf in rat plasma and urine has also been documented employing a reversed‐phase HPLC technique (Geodakyan et al, ; Wang et al, ).…”

Section: Introductionmentioning

confidence: 99%

Elucidation of stress‐induced degradation products of mangiferin: Method development and validation

Khurana

Kaur²,

Kaur³

et al. 2017

Biomedical Chromatography

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The degradation behavior of mangiferin, under various ICH Q1A(R2) recommended stress conditions, was studied using an isocratic elution with mobile phase (pH 2.4), composed of acetonitrile and 1% orthophosphoric acid (12:88 v/v) at a flow rate of 1.0 mL/min, with λ 262 nm. It was suitably adapted for LC-MS studies by replacing with 1% acetic acid (ACN-1% acetic acid; 18:82) and the pH was adjusted to 3.0. Extensive degradation was found to occur during alkaline medium stress studies at 2.31 min of retention time at λ of 235 nm. The mass spectrum of mangiferin, 3 h after treatment with 0.1 M NaOH, clearly shows the rupture of the tricyclic ring, indicating that a fragment at m/z - 269 was formed. Furthermore, the results were supported by nuclear magnetic resonance as well. However, no degradation was observed in other stress conditions.

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ICH Guidance in Practice: Validated Reversed-Phase HPLC Method for the Determination of Active Mangiferin from Extracts of Mangifera indica Linn

Cited by 10 publications

References 0 publications

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

Simultaneous determination of aliskiren and hydrochlorothiazide from their pharmaceutical preparations using a validated stability‐indicating MEKC method

A validated stability-indicating HPLC method for determination of brimonidine tartrate in BRI/PHEMA drug delivery systems

Elucidation of stress‐induced degradation products of mangiferin: Method development and validation

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