Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

Kovács, Béla; Kántor, Lajos Kristóf; Croitoru, Mircea Dumitru; Kelemen, Éva Katalin; Obreja, Mona; Nagy, E; Székely-Szentmiklósi, Blanka; Gyéresi, Árpád

doi:10.2478/acph-2018-0019

Cited by 10 publications

(8 citation statements)

References 11 publications

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“…The stability testing results are similar to the ones obtained in our previous HPLC studies [9]. The degradation profile presents the same level, to a certain extent, regarding hydrolysis, oxidative and photolytic studies for both HPLC and UV-spectrophotometric determinations (Table II and III).…”

Section: Resultssupporting

confidence: 86%

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Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

Kovács

Molnár

Nagy

et al. 2019

Acta Medica Marisiensis

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Objective: The present work offers a fast, reliable and easy UV spectrophotometric method for the assay of strontium ranelate from bulk samples and pharmaceutical dosage form.Methods: The proposed method uses 0.1% V/V trichloroacetic acid as dissolution medium for spectrophotometric analysis, by signal detection at 321 nm. The method was validated according to the currently in-force international guidelines for linearity, accuracy, precision, robustness, limit of detection and quantification.Results: The method was found to be linear in the range of 5-100 µg mL-1 (R2 > 0.999). Method accuracy was found in-between 98.87-100.41%, showing good linear correlation as well (R2 = 0.9997). The concentrations for limit of detection and limit of quantitation were found 1.13 µg mL-1 and 3.77 µg mL-1, resp. The proposed method showed good intra- and interday precision, with low RSD values of 0.53-1.24% and 1.11%, resp.Conclusions: Stability studies performed by both HPLC and UV spectrophotometric methods revealed that the active substance is highly susceptible to acidic hydrolysis, oxidation and exposure to high temperature.

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Section: Resultssupporting

confidence: 86%

“…Literature data revealed that only a few UV spectrophotometric methods have been reported for strontium ranelate so far [3][4][5][6]. Further analytical methods imply RP-HPLC determination [7][8][9][10] and capillary zone electrophoresis [11] for the determination of the active substance.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

Kovács

Molnár

Nagy

et al. 2019

Acta Medica Marisiensis

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“…In the latter case, low model validity was observed, which was due to the high reproducibility of replicate runs and thus, low pure error inside the models. Similar observations were described during several chromatographic method optimizations [26][27][28].…”

Section: Ce Methods Developmentsupporting

confidence: 85%

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

et al. 2021

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is a recently approved drug used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea. Herein, a capillary electrophoretic method was developed, enabling the simultaneous analysis of the API and its S-enantiomer in addition to the enantiomers of its major impurity phenylalaninol. Twenty-nine different cyclodextrins (CDs), including native, neutral, and charged ones were screened as potential chiral selectors, and the best results were obtained with sulfated CDs. Randomly sulfated-β-CD exhibited outstanding enantioresolution, the peaks of phenylalaninol enantiomers inserted between the two peaks of solriamfetol enantiomers, while sulfated-γ-CD (S-γ-CD) showed remarkable resolution values in a much shorter analysis time with the optimal enantiomer migration order. Among the single isomer sulfated CD derivatives, substituent dependent enantiomer migration order reversal could also be observed in the case of heptakis(6-O-sulfo)-β-CD (HS-β-CD) or heptakis(2,3-O-dimethyl-6-O-sulfo)β-CD (HDMS-β-CD) with R-,S-solriamfetol, and heptakis(2,3-O-diacetyl-6-O-sulfo)-β-CD (HDAS-β-CD) resulting S-,R-solriamfetol migration order. The sulfated-γ-CD system was chosen for method optimization applying orthogonal experimental design. The optimized method (45 mM Tris-acetate buffer, pH 4.5, 4 mM S-γ-CD, 21°C, +19.5 kV) was capable for the baseline separation of solriamfetol and phenylalaninol enantiomers within 7 min. The optimized method was validated according to the ICH guidelines and successfully applied for the analysis of pharmaceutical preparation (Sunosi ® 75 mg tablet), thus it may serve as a routine procedure for the laboratories of regulatory authorities as well as in Pharmacopoeias.

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“…Based on the results of these experiments the optimal run conditions can be statistically determined and the outcome of unperformed experiments predicted with high accuracy (21). Pharmaceutical applications of DoE include the development and optimization of single-component (22,23) and multi-component formulations (24,25), as well as the development and validation of analytical methods (26,27).…”

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confidence: 99%

HPLC method development for fampridine using Analytical Quality by Design approach

et al. 2020

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Offering a systematic and multivariate analysis of the analytical procedure, development and validation of HPLC methods using Quality by Design approach are in the limelight of current research trends. A new, experimental design-aided HPLC method for fampridine was developed and preliminarily validated according to current in-force international guidelines for linearity, accuracy, robustness and precision.The method offers a high throughput sample analysis, with an elution time of 2.9 minutes, and signal detection without excipient interference performed at 262 nm. The method proved to be linear between 1–15 µg mL−1 (R2= 0.9996). The mean recovery was found to be 98.7 ± 1.9 % in the tested range of 2.5–7.5 µg mL−1. Low RSD values (< 1 %) were obtained for both model, intra- and inter-day precision. The limit of detection and limit of quantification were 0.24 and 0.78 µg mL−1, resp. The method proved to be applicable for active substance assay in a pharmaceutical dosage form.

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Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design

Cited by 10 publications

References 11 publications

Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

HPLC method development for fampridine using Analytical Quality by Design approach

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