| _version_ | 1866901259865292800 |
|---|---|
| author | Gayathri.N Yasmin.T Idhaya.M Anburaja.R Bharathraj.R Mr. K. PRABAKARAN Astalakshmi.N Surendrakumar.M |
| author_facet | Gayathri.N Yasmin.T Idhaya.M Anburaja.R Bharathraj.R Mr. K. PRABAKARAN Astalakshmi.N Surendrakumar.M |
| contents | <p>Pharmaceutical stability testing plays a crucial role in ensuring the safety, efficacy, and quality of drug products throughout their shelf life. Analytical techniques are widely used in pharmaceutical industries for the qualitative and quantitative estimation of active pharmaceutical ingredients and degradation products. The present study was aimed at the development and validation of a simple, precise, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the estimation of Ormeloxifene Hydrochloride in tablet dosage form. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of Acetonitrile and Tetra methyl ammonium hydroxide (80:20 v/v) adjusted to pH 7.6. Detection was carried out at 280 nm using a UV detector. Accelerated stability studies were performed according to ICH guidelines at storage conditions of 40°C ± 2°C and 75% ± 5% RH for a period of six months. The assay results indicated that the drug remained stable within acceptable limits throughout the study period. The developed method was found to be accurate, precise, reproducible, and suitable for routine quality control analysis and stability studies of Ormeloxifene Hydrochloride tablets.</p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_19438954 |
| institution | Zenodo |
| language | |
| publishDate | 2026 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | STABILITY PROFILING OF ORMELOXIFENE HYDROCHLORIDE USING ACCELERATED TESTING AS PER ICH GUIDELINES Gayathri.N Yasmin.T Idhaya.M Anburaja.R Bharathraj.R Mr. K. PRABAKARAN Astalakshmi.N Surendrakumar.M <p>Pharmaceutical stability testing plays a crucial role in ensuring the safety, efficacy, and quality of drug products throughout their shelf life. Analytical techniques are widely used in pharmaceutical industries for the qualitative and quantitative estimation of active pharmaceutical ingredients and degradation products. The present study was aimed at the development and validation of a simple, precise, and stability-indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method for the estimation of Ormeloxifene Hydrochloride in tablet dosage form. Chromatographic separation was achieved using a C18 column with a mobile phase consisting of Acetonitrile and Tetra methyl ammonium hydroxide (80:20 v/v) adjusted to pH 7.6. Detection was carried out at 280 nm using a UV detector. Accelerated stability studies were performed according to ICH guidelines at storage conditions of 40°C ± 2°C and 75% ± 5% RH for a period of six months. The assay results indicated that the drug remained stable within acceptable limits throughout the study period. The developed method was found to be accurate, precise, reproducible, and suitable for routine quality control analysis and stability studies of Ormeloxifene Hydrochloride tablets.</p> |
| title | STABILITY PROFILING OF ORMELOXIFENE HYDROCHLORIDE USING ACCELERATED TESTING AS PER ICH GUIDELINES |
| url | https://doi.org/10.5281/zenodo.19438954 |