Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design
A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental desi...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2018-06-01
|
| Series: | Acta Pharmaceutica |
| Subjects: | |
| Online Access: | https://doi.org/10.2478/acph-2018-0019 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832574183753646080 |
|---|---|
| author | Kovács Béla Kántor Lajos Kristóf Croitoru Mircea Dumitru Kelemen Éva Katalin Obreja Mona Nagy Előd Ernő Székely-Szentmiklósi Blanka Gyéresi Árpád |
| author_facet | Kovács Béla Kántor Lajos Kristóf Croitoru Mircea Dumitru Kelemen Éva Katalin Obreja Mona Nagy Előd Ernő Székely-Szentmiklósi Blanka Gyéresi Árpád |
| author_sort | Kovács Béla |
| collection | DOAJ |
| description | A reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental design was used to demonstrate the robustness of the method. Strontium ranelate was eluted at 4.4 minutes and showed no interference with the excipients used in the formulation, at 321 nm. The method is linear in the range of 20–320 μg mL−1 (R2 = 0.99998). Recovery, tested in the range of 40–120 μg mL−1, was found to be 96.1–102.1 %. Intra-day and intermediate precision RSDs ranged from 1.0–1.4 and 1.2–1.4 %, resp. The limit of detection and limit of quantitation were 0.06 and 0.20 μg mL−1, resp. The proposed technique is fast, cost-effective, reliable and reproducible, and is proposed for the routine analysis of strontium ranelate. |
| format | Article |
| id | doaj-art-b6748c7b5f0a4760b9fb8cb554bc2353 |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2018-06-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-b6748c7b5f0a4760b9fb8cb554bc23532025-02-02T00:31:54ZengSciendoActa Pharmaceutica1846-95582018-06-0168217118310.2478/acph-2018-0019acph-2018-0019Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental designKovács Béla0Kántor Lajos Kristóf1Croitoru Mircea Dumitru2Kelemen Éva Katalin3Obreja Mona4Nagy Előd Ernő5Székely-Szentmiklósi Blanka6Gyéresi Árpád7Gedeon Richter Romania, 540306, Tîrgu Mureș, RomaniaGedeon Richter Romania, 540306, Tîrgu Mureș, RomaniaDepartment of Toxicology and Biopharmacy, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu MureșRomaniaGedeon Richter Romania, 540306, Tîrgu Mureș, RomaniaGedeon Richter Romania, 540306, Tîrgu Mureș, RomaniaDepartment of Biochemistry and Environmental Chemistry, Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu Mureș, RomaniaDepartment of Pharmaceutical Chemistry Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu MureșRomaniaDepartment of Pharmaceutical Chemistry Faculty of Pharmacy, University of Medicine and Pharmacy, 540139, Tîrgu MureșRomaniaA reverse-phase HPLC (RP-HPLC) method was developed for strontium ranelate using a full factorial, screening experimental design. The analytical procedure was validated according to international guidelines for linearity, selectivity, sensitivity, accuracy and precision. A separate experimental design was used to demonstrate the robustness of the method. Strontium ranelate was eluted at 4.4 minutes and showed no interference with the excipients used in the formulation, at 321 nm. The method is linear in the range of 20–320 μg mL−1 (R2 = 0.99998). Recovery, tested in the range of 40–120 μg mL−1, was found to be 96.1–102.1 %. Intra-day and intermediate precision RSDs ranged from 1.0–1.4 and 1.2–1.4 %, resp. The limit of detection and limit of quantitation were 0.06 and 0.20 μg mL−1, resp. The proposed technique is fast, cost-effective, reliable and reproducible, and is proposed for the routine analysis of strontium ranelate.https://doi.org/10.2478/acph-2018-0019strontium ranelatehplcexperimental designfull factorial design |
| spellingShingle | Kovács Béla Kántor Lajos Kristóf Croitoru Mircea Dumitru Kelemen Éva Katalin Obreja Mona Nagy Előd Ernő Székely-Szentmiklósi Blanka Gyéresi Árpád Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design Acta Pharmaceutica strontium ranelate hplc experimental design full factorial design |
| title | Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design |
| title_full | Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design |
| title_fullStr | Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design |
| title_full_unstemmed | Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design |
| title_short | Reversed phase HPLC for strontium ranelate: Method development and validation applying experimental design |
| title_sort | reversed phase hplc for strontium ranelate method development and validation applying experimental design |
| topic | strontium ranelate hplc experimental design full factorial design |
| url | https://doi.org/10.2478/acph-2018-0019 |
| work_keys_str_mv | AT kovacsbela reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT kantorlajoskristof reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT croitorumirceadumitru reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT kelemenevakatalin reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT obrejamona reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT nagyeloderno reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT szekelyszentmiklosiblanka reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign AT gyeresiarpad reversedphasehplcforstrontiumranelatemethoddevelopmentandvalidationapplyingexperimentaldesign |