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

Moustapha E Moustapha; Mehnaz Kamal; Rania M Elgamal

doi:10.1016/j.jsps.2020.08.020

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

Saudi Pharm J. 2020 Nov;28(11):1301-1308. doi: 10.1016/j.jsps.2020.08.020. Epub 2020 Sep 2.

Authors

Moustapha E Moustapha^{1

2}, Mehnaz Kamal³, Rania M Elgamal^{4

3}

Affiliations

¹ Department of Chemistry, College of Science and Humanities, Prince Sattam bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
² University Central Laboratory, College of Science and Humanities, Prince Sattam bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
³ Department of Pharmaceutical Chemistry, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia.
⁴ Department of Pharmaceutical Analytical Chemistry, College of Pharmacy, Mansoura University, Mansoura, Egypt.

Abstract

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 min. 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.

Keywords: % CV, The coefficient of variation; AV, Acceptance value; Actonel® tablets; Content uniformity; DAD, Diode Array Detector; Dissolution testing; HPLC-UV method; HPLC-UV, High-pressure liquid chromatography-ultra violet detection; HQC, High quality control; LQC, Low quality control; MQC, Medium quality control; N, Number of theoretical plates; NaOH, Sodium hydroxide; RSD, Relative standard deviation; RT, Room temperature; Risedronate; Rt, Retention time; SD, Standard deviation; SST, System suitability study; Tf, USP tailing factor; USFDA, US Food and Drug Administration; USP, United States Pharmacopoeia; Validation; k, Capacity factor; r2, Coefficient of correlation; °C, Degree Celsius; μL, Microlitre.