2nd International Conference on Fostering Interdisciplinary Research In Health Sciences (ICFIRHS) 2019 (01-May-2019)        |

Journal :   Research Journal of Pharmacy and Technology

Volume No. :   11

Issue No. :  10

Year :  2018

Pages :   4332-4338

ISSN Print :  0974-3618

ISSN Online :  0974-360X


Registration

Allready Registrered
Click to Login

Stability-indicating HPLC Method for Determination of Naproxen in an Extemporaneous Suspension



Address:   Nuttapon Songnaka1, Somchai Sawatdee1,2, Apichart Atipairin1,2*
1School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand.
2Drug and Cosmetic Excellence Center, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand.
*Corresponding Author
DOI No: 10.5958/0974-360X.2018.00793.X

ABSTRACT:
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used for treatment of fever and inflammation. It is mostly available as tablet dosage form. Hospital pharmacists always prepare the drug in an orally liquid preparation such as suspension for pediatric use. To determine the amount of naproxen in an extemporaneous preparation and during stability studies, a HPLC method was developed and validated by following the Asean guideline for validation of the analytical procedure. The method used a C18 column as the stationary phase whereas the mobile phase was a mixture of 50 mM sodium phosphate buffer pH 7.8 and acetronitrile (70:30). The flow rate was 0.7 ml/min and injection volume was 20 µl. The drug was measured at 230 nm. The result showed that the retention time of naproxen was about 8.18 min, and the method was specific to the drug in the presence of other common excipients in the preparation. It was accurate (97.45 ± 0.63%) and precise (1.33-2.33% RSD). It was linear in the concentration range of 2.56 ng/ml- 50 µg/ml (R2= 0.9999). The limit of detection (LOD) and limit of quantification (LOQ) were 0.19 and 0.59 µg/ml, respectively. Minor changes of flow rate, mobile phase composition, wavelength and injection volume slightly affected the drug analysis. Forced degradation studies (hydrolysis, oxidation and temperature) showed that the method was served as a stability-indicating procedure. It demonstrated that the validated method was simple, reliable, accurate and robust to determine naproxen in the extemporaneous suspension. In addition, it could use for analysis of the drug in the stability studies.
KEYWORDS:
ASEAN Guideline; Extemporaneous Suspension; HPLC Method; Naproxen; Validation.
Cite:
Nuttapon Songnaka, Somchai Sawatdee, Apichart Atipairin. Stability-indicating HPLC Method for Determination of Naproxen in an Extemporaneous Suspension. Research J. Pharm. and Tech 2018; 11(10): 4332-4338.
[View HTML]     



Visitor's No. :   556393