Stability-indicating LC method for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha-tocopherol contents in marijuana capsules

Dongala, Thirupathi; Palakurthi, Ashok Kumar

doi:10.1007/s13738-019-01799-9

Cited by 6 publications

(4 citation statements)

References 31 publications

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“…The proposed method was validated according to the ICH guidelines (International Conference on Harmonization 2005; Dongala et al, 2019) for system suitability, specificity, recovery, precision, linearity, robustness, LOD, and LOQ.…”

Section: Resultsmentioning

confidence: 99%

“…HPLC is a powerful analytical tool to rapidly develop stability‐inducing methods. The importance of HPLC in developing simple and rapid stability‐inducing methods has been explained previously (Dongala, Katari, Palakurthi, & Jonnalagadda 2019a, 2019b; Dongala, Palakurthi Vytla, & Karati, 2019; Dongala & Palakurthi, 2019). Based on the aforesaid studies, were choose HPLC to estimate MET, LIN, and EMP in pharmaceutical dosage forms.…”

Section: Introductionmentioning

confidence: 89%

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Stability‐indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form

Vankalapati

Alegete

Boodida

2020

Biomedical Chromatography

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A rapid stability‐indicating reversed phase‐ultrapure liquid chromatography (RP‐UPLC) was developed and validated for the estimation of metformin (MET), linagliptin (LIN), and empagliflozin (EMP) combination in bulk and tablet dosage form using Kromasil C18 column (2.1 × 50 mm, 1.8 μm) as a stationary phase and a mixture solution of 40% phosphate buffer (pH = 3) and 60% acetonitrile as mobile phase at a flow rate of 0.6 mL/min. The detection was performed at 248 nm using a photodiode array detector. The linearity, sensitivity, selectivity, robustness, specificity, precision, and accuracy were determined. The peak area response–concentration curve was rectilinear over the range of 50–150 (MET), 5–15 (LIN), and 10–30 μg/mL (EMP) with quantitation limits of 0.042 (MET), 0.023 (LIN), and 0.059 μg/mL (EMP). The proposed method was successfully validated for the determination of MET, LIN, and EMP simultaneously in combined tablet dosage form. The performance of the proposed method was compared with reported RP‐UPLC methods and found to be rapid and economical. The developed and validated stability‐indicating RP‐UPLC method was appropriate for the quality control and drug analysis.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 89%

Stability‐indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form

Vankalapati

Alegete

Boodida

2020

Biomedical Chromatography

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“…The purpose of the stabilityindicating analytical method is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of various environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or shelf life for the drug product and recommended storage condition [17][18][19][20]. Dongala et al [21] have demonstrated the importance of stability-indicating in the pharmaceutical industry. The presence of impurities in drug substance or drug product will affect the product's quality even at a very low level.…”

Section: Introductionmentioning

confidence: 99%

“…Dongala et al. [21] have demonstrated the importance of stability‐indicating in the pharmaceutical industry. The presence of impurities in drug substance or drug product will affect the product's quality even at a very low level.…”

Section: Introductionmentioning

confidence: 99%

A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

Subramanian

Konduru

Katari

et al. 2020

Separation Science Plus

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The current study is to develop a simple high-performance liquid chromatography method for Carbidopa and Levodopa impurities' simultaneous determination with the combination of Entacapone in solid oral dosage forms. The estimation of impurities are critical in a combination product due to the more number of impurities. The presence of impurities in drug products affects quality and bio-efficacy. The quality by design approach allows the assessment of various analytical parameters and their effects with the minimum number of experiments. The current high-performance liquid chromatography method was developed using a kromasil column with gradient mobile phase. The detection was made 220 nm; the flow rate was 1.0 mL/min, and the column's temperature was 25 • C. The analytical curves presented a coefficient of correlation of >0.99, and detection and quantification limits were evaluated for all impurities. Excellent precision and accuracy were obtained for carbidopa and levodopa impurities. Intra-and interday precisions RSD were lower than 10.0, and recoveries of impurities varied between 91.2 and 108.2%. The results reveal the method's successful applicability for estimating Carbidopa and Levodopa with their process and degradation impurities from its marketed formulation.

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Application of dispersive liquid–liquid extraction followed by rapid and direct mass spectrometry analysis to evaluate parabens in high salinity water sample

Jiang,

Bian,

Zhang

et al. 2023

Microchemical Journal

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Stability-indicating LC method for the simultaneous determination of methyl paraben, propyl paraben, butylated hydroxytoluene and alpha-tocopherol contents in marijuana capsules

Cited by 6 publications

References 31 publications

Stability‐indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form

Stability‐indicating ultra performance liquid chromatography method development and validation for simultaneous estimation of metformin, linagliptin, and empagliflozin in bulk and pharmaceutical dosage form

A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

Application of dispersive liquid–liquid extraction followed by rapid and direct mass spectrometry analysis to evaluate parabens in high salinity water sample

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