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- Title
Development and Validation of an UV-Spectrophotometric Method for the Assay of Strontium Ranelate and HPLC Stability Testing from Bulk and Pharmaceutical Dosage Form.
- Authors
Kovács, Béla; Molnár, Réka; Nagy, Előd Ernő; Kelemen, Éva Katalin; Székely-Szentmiklósi, Blanka; Székely-Szentmiklósi, István; Kovács-Deák, Boglárka; Gyéresi, Árpád
- Abstract
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.
- Subjects
DOSAGE forms of drugs; STRONTIUM; DETECTION limit; SIGNAL detection; ULTRAVIOLET spectrophotometry
- Publication
Acta Medica Marisiensis, 2019, Vol 65, Issue 2, p55
- ISSN
2068-3324
- Publication type
Article
- DOI
10.2478/amma-2019-0014