QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form

Palakurthi, Ashok Kumar; Dongala, Thirupathi; Katakam, Lakshmi Narasimha Rao

doi:10.1016/j.plabm.2020.e00169

Cited by 31 publications

(16 citation statements)

References 19 publications

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“…The method was validated according to International Conference on Harmonization (ICH) guidelines. The following characteristics were evaluated: linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness, and stability-indicating capability (ICH, 1997;Palakurthi et al, 2020).…”

Section: Methods Validationmentioning

confidence: 99%

A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

Kokkirala

Prasad

Alegete

et al. 2021

Biomedical Chromatography

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A novel method was developed for the simultaneous estimation of the doravirine, lamivudine, and tenofovir disoproxil fumarate in the pharmaceutical dosage form.The chromatogram was run through an Ascentis C18 column (150 Â 4.6 mm, 2.7 μm), with the mobile phase consisting of a phosphate buffer and acetonitrile in the ratio of 50:50 (v/v). The mobile phase was pumped through the column at a flow rate of 1 mL/min. The column temperature was maintained at 30 C. The optimized wavelength for doravirine, lamivudine, and tenofovir disoproxil fumarate was 230.0 nm.

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Section: Methods Validationmentioning

confidence: 99%

A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

Kokkirala

Prasad

Alegete

et al. 2021

Biomedical Chromatography

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“…The forced degradation study was performed to prove the stability‐indicating nature of the method. During the method development specificity is the important factor to prove the stability‐indicating nature of the method (Palakurthi, Dongala, & Katakam, 2020; Palakurthi, Raju, & Dongala, 2013; Palakurthi, Thirupathi, Kumar, & Jayashree, 2017). We performed the following studies: alkaline, acidic, oxidative stress, thermal, water, and direct exposure to UV.…”

Section: Methodsmentioning

confidence: 99%

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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“…This study was performed to identify the molecule behavior during the different stress conditions [29][30][31][32][33]. The degradation impurities, process impurities, and unknown impurities were well resolved and determined.…”

Section: Forced Degradation Studymentioning

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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QbD based development of HPLC method for simultaneous quantification of Telmisartan and Hydrochlorothiazide impurities in tablets dosage form

Cited by 31 publications

References 19 publications

A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral 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

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