A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES
A stability-indicating LC method was developed on ion exchange chromatography equipped with refractive index detector for the quantification of phosphite, phosphate content and assay of alendronic acid in pharmaceutical dosage forms. The isocratic separation was achieved by using Allsep anion (150mm...
Guardado en:
| Autores principales: | , , , |
|---|---|
| Lenguaje: | English |
| Publicado: |
Sociedad Chilena de Química
2012
|
| Materias: | |
| Acceso en línea: | http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300007 |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:scielo:S0717-97072012000300007 |
|---|---|
| record_format |
dspace |
| spelling |
oai:scielo:S0717-970720120003000072019-02-19A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLESSunil Reddy,PSudhakar Babu,KKumar,NavneetBalakrishna,P Ion exchange chromatography Refractive index detector Phosphate Phosphite Alendronate sodium A stability-indicating LC method was developed on ion exchange chromatography equipped with refractive index detector for the quantification of phosphite, phosphate content and assay of alendronic acid in pharmaceutical dosage forms. The isocratic separation was achieved by using Allsep anion (150mm x 4.6mm) 7 µm column with mobile phase containing a 5.3 mM formic acid, pH adjusted to 3.5 with sodium hydroxide solution at a flow rate of 1.2 mL/min. Alendronate sodium was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Alendronate sodium was found to degrade significantly in oxidative stress conditions only. The developed method was extensively validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and robustness. The developed LC method was successfully applied for analysis of in-vitro dissolution samples of marketed alendronate sodium tablets.info:eu-repo/semantics/openAccessSociedad Chilena de QuímicaJournal of the Chilean Chemical Society v.57 n.3 20122012-01-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300007en10.4067/S0717-97072012000300007 |
| institution |
Scielo Chile |
| collection |
Scielo Chile |
| language |
English |
| topic |
Ion exchange chromatography Refractive index detector Phosphate Phosphite Alendronate sodium |
| spellingShingle |
Ion exchange chromatography Refractive index detector Phosphate Phosphite Alendronate sodium Sunil Reddy,P Sudhakar Babu,K Kumar,Navneet Balakrishna,P A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| description |
A stability-indicating LC method was developed on ion exchange chromatography equipped with refractive index detector for the quantification of phosphite, phosphate content and assay of alendronic acid in pharmaceutical dosage forms. The isocratic separation was achieved by using Allsep anion (150mm x 4.6mm) 7 µm column with mobile phase containing a 5.3 mM formic acid, pH adjusted to 3.5 with sodium hydroxide solution at a flow rate of 1.2 mL/min. Alendronate sodium was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Alendronate sodium was found to degrade significantly in oxidative stress conditions only. The developed method was extensively validated as per ICH guidelines with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and robustness. The developed LC method was successfully applied for analysis of in-vitro dissolution samples of marketed alendronate sodium tablets. |
| author |
Sunil Reddy,P Sudhakar Babu,K Kumar,Navneet Balakrishna,P |
| author_facet |
Sunil Reddy,P Sudhakar Babu,K Kumar,Navneet Balakrishna,P |
| author_sort |
Sunil Reddy,P |
| title |
A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| title_short |
A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| title_full |
A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| title_fullStr |
A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| title_full_unstemmed |
A VALIDATED STABILITY INDICATING ION EXCHANGE CHROMATOGRAPHIC METHOD FOR THE QUANTIFICATION OF ALENDRONATE, PHOSPHITE AND PHOSPHATE IN ALENDRONATE SODIUM TABLETS AND ANALYSIS OF IN-VITRO DISSOLUTION SAMPLES |
| title_sort |
validated stability indicating ion exchange chromatographic method for the quantification of alendronate, phosphite and phosphate in alendronate sodium tablets and analysis of in-vitro dissolution samples |
| publisher |
Sociedad Chilena de Química |
| publishDate |
2012 |
| url |
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0717-97072012000300007 |
| work_keys_str_mv |
AT sunilreddyp avalidatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT sudhakarbabuk avalidatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT kumarnavneet avalidatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT balakrishnap avalidatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT sunilreddyp validatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT sudhakarbabuk validatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT kumarnavneet validatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples AT balakrishnap validatedstabilityindicatingionexchangechromatographicmethodforthequantificationofalendronatephosphiteandphosphateinalendronatesodiumtabletsandanalysisofinvitrodissolutionsamples |
| _version_ |
1718445468908781568 |