A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug
A new naproxen amide prodrug was synthesized and spectrally characterized and a simple, precise, and accurate stability-indicating RP-HPLC method was developed and validated for determination and chemical hydrolysis study of the prodrug. Forced degradation studies were conducted as per the Internati...
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2017-01-01
|
| Series: | Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2017/5285671 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832567111824703488 |
|---|---|
| author | Mohamed H. M. Hamid Tilal Elsaman |
| author_facet | Mohamed H. M. Hamid Tilal Elsaman |
| author_sort | Mohamed H. M. Hamid |
| collection | DOAJ |
| description | A new naproxen amide prodrug was synthesized and spectrally characterized and a simple, precise, and accurate stability-indicating RP-HPLC method was developed and validated for determination and chemical hydrolysis study of the prodrug. Forced degradation studies were conducted as per the International Conference on Harmonization (ICH) guidelines to establish the stability-indicating power of the method. Separations were performed on a C18 column (150 × 4.6 mm i.d., 5 μm p.s.). The mobile phase consisted of acetonitrile and phosphate buffer pH 4.0 in the ratio 60 : 40. The flow rate and injection volume were 1.0 mL/min and 15 μL, respectively. The peaks were monitored at 272 nm. The average retention time is 5.136 min. The linearity of the method was investigated in the range of 10–50 μg/mL and r2 was found to be larger than 0.9987. The LOD and LOQ were found to be 1.853 and 5.615 μg/mL, respectively. Results indicated that the degradants are well resolved and separated from the prodrug. Hydrolysis kinetics studies were carried out in buffer solutions (pH 1.2, 5.5 and 7.4) to establish the fate of the prodrug. The half-lives in the respective buffers were 23.5, 262, and 334 hours indicating sufficient stability to attain the goal of oral delivery. |
| format | Article |
| id | doaj-art-8dcfb16e044c420e9ebbe4609514e916 |
| institution | Kabale University |
| issn | 2090-9063 2090-9071 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Chemistry |
| spelling | doaj-art-8dcfb16e044c420e9ebbe4609514e9162025-02-03T01:02:23ZengWileyJournal of Chemistry2090-90632090-90712017-01-01201710.1155/2017/52856715285671A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen ProdrugMohamed H. M. Hamid0Tilal Elsaman1Department of Pharmaceutical Chemistry, College of Pharmacy, Omdurman Islamic University, P.O. Box 2587, 11452 Khartoum, SudanDepartment of Pharmaceutical Chemistry, College of Pharmacy, Omdurman Islamic University, P.O. Box 2587, 11452 Khartoum, SudanA new naproxen amide prodrug was synthesized and spectrally characterized and a simple, precise, and accurate stability-indicating RP-HPLC method was developed and validated for determination and chemical hydrolysis study of the prodrug. Forced degradation studies were conducted as per the International Conference on Harmonization (ICH) guidelines to establish the stability-indicating power of the method. Separations were performed on a C18 column (150 × 4.6 mm i.d., 5 μm p.s.). The mobile phase consisted of acetonitrile and phosphate buffer pH 4.0 in the ratio 60 : 40. The flow rate and injection volume were 1.0 mL/min and 15 μL, respectively. The peaks were monitored at 272 nm. The average retention time is 5.136 min. The linearity of the method was investigated in the range of 10–50 μg/mL and r2 was found to be larger than 0.9987. The LOD and LOQ were found to be 1.853 and 5.615 μg/mL, respectively. Results indicated that the degradants are well resolved and separated from the prodrug. Hydrolysis kinetics studies were carried out in buffer solutions (pH 1.2, 5.5 and 7.4) to establish the fate of the prodrug. The half-lives in the respective buffers were 23.5, 262, and 334 hours indicating sufficient stability to attain the goal of oral delivery.http://dx.doi.org/10.1155/2017/5285671 |
| spellingShingle | Mohamed H. M. Hamid Tilal Elsaman A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug Journal of Chemistry |
| title | A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug |
| title_full | A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug |
| title_fullStr | A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug |
| title_full_unstemmed | A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug |
| title_short | A Stability-Indicating RP-HPLC-UV Method for Determination and Chemical Hydrolysis Study of a Novel Naproxen Prodrug |
| title_sort | stability indicating rp hplc uv method for determination and chemical hydrolysis study of a novel naproxen prodrug |
| url | http://dx.doi.org/10.1155/2017/5285671 |
| work_keys_str_mv | AT mohamedhmhamid astabilityindicatingrphplcuvmethodfordeterminationandchemicalhydrolysisstudyofanovelnaproxenprodrug AT tilalelsaman astabilityindicatingrphplcuvmethodfordeterminationandchemicalhydrolysisstudyofanovelnaproxenprodrug AT mohamedhmhamid stabilityindicatingrphplcuvmethodfordeterminationandchemicalhydrolysisstudyofanovelnaproxenprodrug AT tilalelsaman stabilityindicatingrphplcuvmethodfordeterminationandchemicalhydrolysisstudyofanovelnaproxenprodrug |