| Submission to first decision
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3 weeks |
|---|---|
| Submission to decision after review (For papers that are sent to review, the average time from submission to receipt of first editor decision) | 6 weeks |
| Submission to final decision (The average time from manuscript submission to the final editorial decision) | 16 weeks |
| Submission to publication (The average time from acceptance to publication. Manuscript published in early view are also included in this calculation) | 24 weeks |
ACTA Pharmaceutica Sciencia
2025 , Vol 63 , Num 1
Stability indicating RP-HPLC method development for ondansetron hydrochloride estimation in bulk
1 University of Mumbai, School of Pharmacy, Department of Quality Assurance, Navi Mumbai, India2 University of Mumbai, School of Pharmacy, Department of Pharmaceutics, Navi Mumbai, India
DOI : 10.23893/1307-2080.APS6309 Viewed : 3266 - Downloaded : 2511 To determine ondansetron hydrochloride in bulk drug, an easy, fast, sensitive, and discerning stability-indicating (RP-HPLC) approach is proposed. Ondansetron hydrochloride was eluted from C18 column (4.6 × 250 mm, 5 µm) and mobile phase containing methanol, acetonitrile and water (50: 30: 20 v/v/v). According to ICH Q2 (R1) guidelines, the entire analytical technique validation was completed. The results of the retrieval study, which was conducted at working concentration levels between 80 to 120%, ranged from 99% to 101%. With a linear regression curve (R2=0.9941), the linearity was assessed in the working concentration range of 5-35 ?g mL-1, with a limit of quantitation (LOQ) and detection (LOD) of 0.2559 ?g mL-1 and 0.7755 ?g mL-1, respectively. Ondansetron hydrochloride showed a retention time of 4.997 min. The approach exhibited good recovery with relative standard deviations under 2% for intra and inter-day precision. Keywords : ondansetron hydrochloride, RP-HPLC, ICH guidelines, validation, stability studies