An eco-friendly HPLC-UV method for the determination of risedronate in its bulk and tablet dosage form with application to content uniformity, dissolution and stability testing
| Autor: | Rania M. El-Gamal, Mehnaz Kamal, Moustapha E. Moustapha |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Actonel® tablets
Potassium Pharmaceutical Science chemistry.chemical_element k Capacity factor DAD Diode Array Detector USFDA US Food and Drug Administration 01 natural sciences NaOH Sodium hydroxide Dosage form RSD Relative standard deviation chemistry.chemical_compound HPLC-UV High-pressure liquid chromatography-ultra violet detection Potassium phosphate Content uniformity RT Room temperature Validation LQC Low quality control % CV The coefficient of variation μL Microlitre SD Standard deviation Dissolution testing HQC High quality control USP United States Pharmacopoeia Dissolution Phosphoric acid r2 Coefficient of correlation Tf USP tailing factor Rt Retention time Pharmacology Risedronate Chromatography 010405 organic chemistry Elution AV Acceptance value lcsh:RM1-950 010401 analytical chemistry SST System suitability study HPLC-UV method 0104 chemical sciences Risedronate Sodium lcsh:Therapeutics. Pharmacology °C Degree Celsius chemistry N Number of theoretical plates Original Article MQC Medium quality control |
| Zdroj: | Saudi Pharmaceutical Journal : SPJ Saudi Pharmaceutical Journal, Vol 28, Iss 11, Pp 1301-1308 (2020) |
| ISSN: | 2213-7475 1319-0164 |
| Popis: | Risedronate is a nitrogen-containing bisphosphonate for the treatment and prevention of postmenopausal osteoporosis. The current work aims to develop a novel green HPLC-UV method for the rapid analysis of risedronate sodium in bulk and tablet formulation. The analyzed samples were separated on Waters Atlantis dC18 (150 mm × 3.9 mm; 5 μm) column using a green mobile phase consisting of potassium phosphate buffer pH 2.9 and potassium edetate buffer pH 9.5 in a ratio of 1:2, the final pH was adjusted to 6.8 with phosphoric acid, the mobile phase was pumped at a rate of 1.0 mL/min, with column temperature set at 30°C, eluted samples were detected at 263 nm and the chromatographic run time was 3.0 minutes. The method was found to be linear over the concentration range of 14-140 μg/mL with a correlation coefficient (r2) of 0.9994. Accuracy and precision were evaluated from three QC samples (LQC, MQC and HQC) together with the five calibrators where the percentage accuracy was found to be 101.84%. Processed quality control samples of risedronate sodium were tested for stability at different conditions, short term, long term and freeze- thaw stability. The current method was further extended to study the content uniformity of Actonel® tablets following United States Pharmacopoeia (USP) guidelines. The proposed method was fully validated as per ICH guidelines. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|