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, Velusamy B.; Konduru, Naresh; Katari, Naresh Kumar; Dongala, Thirupathi; Gundla, Rambabu

doi:10.1002/sscp.202000029

Cited by 28 publications

(15 citation statements)

References 20 publications

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“…Aim: Stability‐indicating method development and validation for the determination of progesterone in the vaginal gel. Some critical information about progesterone, such as pKa value, solubility, melting point, and polarity (mid‐polar) of the compound was collected from the literature (Subramanian et al, 2020), and different experimental trials were designed. Experiment 1 involved the identification of retention time of progesterone peak.…”

Section: Resultsmentioning

confidence: 99%

Determination of progesterone (steroid drug) in the semi‐solid dosage form (vaginal gel) using a stability‐indicating method by RP‐HPLC/PDA detector

Konduru¹,

Kethe²,

Gundla

et al. 2021

Biomedical Chromatography

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A simple stability‐indicating method was developed and validated for the determination of progesterone (a steroid drug) in the semi‐solid dosage form. All the impurities were separated from the main compound with a simple stationary phase (Eclipse XDB, C8, 150 × 4.6 mm, 5 μm). The mobile phase A contained phosphate buffer and acetonitrile in the ratio of 90:10, v/v, and mobile phase B contained purified water and acetonitrile in the ratio of 10:90, v/v. The optimized chromatographic conditions were as follows: flow rate, 1.0 mL min−1; UV detection, 241 nm; injection volume, 10 μL; and the column temperature, 30°C. The method was validated as per the current ICH Q2 guidelines. The recovery study and linearity ranges were established from 50 to 300% optimal concentrations. The method validation results were found between 98 and 102% for accuracy and r2 = 0.999 for linearity. Forced degradation in hydrolytic, oxidative, thermolytic, and photostability conditions was performed, and the stability indicating nature of the method was proved. Based on the validation and forced degradation results, the current method was found to be specific, precise, accurate, linear, robust, and stability‐indicating method. The developed method was cost effective and easy to handle for quality control analysis.

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Section: Resultsmentioning

confidence: 99%

Determination of progesterone (steroid drug) in the semi‐solid dosage form (vaginal gel) using a stability‐indicating method by RP‐HPLC/PDA detector

Konduru¹,

Kethe²,

Gundla

et al. 2021

Biomedical Chromatography

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“…The current regulatory framework requires conducting forced degradation experiments under a variety of conditions and the separation of drugs from degradation products (Jain & Basniwal, 2013; Subramanian, Konduru, et al, 2020; Thirupathi et al, 2018). The forced degradation study was evaluated for acid, base, peroxide, thermal, UV, and water.…”

Section: Resultsmentioning

confidence: 99%

A rapid RP‐HPLC stability‐indicating method development and validation of moxifloxacin hydrochloride–related substances in finished dosage forms

Vankalapati

Algete

Boodida

2021

Biomedical Chromatography

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A reversed‐phase high‐performance liquid chromatography (RP‐HPLC) method was developed and validated for the identification and quantification of moxifloxacin hydrochloride–related substances in finished dosage forms. Chromatographic separation was achieved on an Agilent C18 column (150 × 4.6 mm, 5 μm) with the mobile phase (0.01 M potassium dihydrogen orthophosphate as buffer and methanol in the ratio of 70:30) eluted in isocratic mode. The HPLC flow rate was 1.0 mL min−1, and peaks were monitored at 230 nm using a photodiode array (PDA) detector. The column temperature was kept constant at 30°C, and the injection volume was 10 μL. The run time of the method was 16 min. The method was validated as per the International Conference on Harmonization (ICH) guidelines. Linearity was recorded at various concentrations ranging from 0.25 to 1.5 μg mL−1 for all the moxifloxacin impurities. Linearity, regression value, recovery, %relative standard deviation (RSD) of method precision values were found within the acceptance limits. The method for related substances (RS) in moxifloxacin was found to be specific, linear, accurate, precise, rugged, and robust. The validated method was suitable for the quantification of the RSs in moxifloxacin drug products. The method was applied in quality control lab for the analysis of moxifloxacin impurities in stability analysis.

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“…The current method’s stability-indicating nature was proven by conducting acid, base, peroxide, thermal, and light degradation studies. 25 Degradation results expressed that the formulation product was sensitive to all the conditions. The major degradants were CMN EP impurity E and CMN EP impurity F. These peaks clearly separated from the three analytes.…”

Section: Methodsmentioning

confidence: 99%

Green Chromatographic Method for Determination of Active Pharmaceutical Ingredient, Preservative, and Antioxidant in an Injectable Formulation: Robustness by Design Expert

Kowtharapu

Katari

Sandoval³

et al. 2022

ACS Omega

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We report an efficient HPLC method for simultaneous qualitative and quantitative analysis of lincosamide antibiotic injectable formulations containing Clindamycin phosphate (CMN), benzyl alcohol (BA), and ethylenediaminetetraacetic acid (EDTA) as major ingredients. The three components were separated by Phenomenex prodigy C8 (250 mm × 4.6 mm, 5 μm) HPLC column, flow rate 1.1 mL/min, injection volume 30 μL, and column temperature 35 °C, using 0.05 M sodium acetate buffer (pH 4.5) with acetonitrile (ACN) in the ratio of 80:20 (v/v). The detection wavelength was set as 240 nm. The method was validated as per International Conference on Harmonization (ICH) guidelines and was confirmed to be specific, precise, accurate, and linear. Method robustness was executed by utilizing quality in the design of the experiment. Accuracy results were found to be 99.3–100.5% for CMN, 99.3–100.8% for BA, and 99.1–100.3% for EDTA. Precision results were obtained as % relative standard deviation (RSD): 0.6% for CMN, 0.4% for BA, and 0.4% for EDTA. Correlation coefficient ( r 2 ) values were obtained as >0.999 for the three components. Analytical solutions are stable for 48 h at benchtop and refrigerator conditions. The greenness of the analytical method was evaluated by the Green Analytical Procedure Index (GAPI), National Environmental Method Index (NEMI), analytical eco-scale, and Analytical Greenness (AGREE) tools to confirm that the method is eco-friendly.

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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

Cited by 28 publications

References 20 publications

Determination of progesterone (steroid drug) in the semi‐solid dosage form (vaginal gel) using a stability‐indicating method by RP‐HPLC/PDA detector

Determination of progesterone (steroid drug) in the semi‐solid dosage form (vaginal gel) using a stability‐indicating method by RP‐HPLC/PDA detector

A rapid RP‐HPLC stability‐indicating method development and validation of moxifloxacin hydrochloride–related substances in finished dosage forms

Green Chromatographic Method for Determination of Active Pharmaceutical Ingredient, Preservative, and Antioxidant in an Injectable Formulation: Robustness by Design Expert

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