| Title: |
CO-ESTIMATION OF SAXAGLIPTIN AND ENALAPRIL IN LIPOSPHERES: HPLC METHOD DEVELOPMENT, VALIDATION AND OPTIMIZATION USING RESPONSE SURFACE TECHNIQUE. |
| Authors: |
MAHEEN, SAFIRAH, RASUL, AKHTAR, KHAN, HAFEEZ U., ABBAS, GHULAM, SAADULLAH, MALIK, AFZAL, SAMINA, SHARIF, MARIAM, AFZAL, KHURRAM, TARIQ, FATIMA, SHAH, PERVAIZ A. |
| Source: |
Acta Poloniae Pharmaceutica; Sep/Oct2020, Vol. 77 Issue 5, p673-684, 12p |
| Subject Terms: |
ENALAPRIL, HIGH performance liquid chromatography, RESPONSE surfaces (Statistics), STATISTICAL correlation, DRUGS |
| Abstract: |
The co-existence of hypertension with diabetes demands combination therapy. Therefore, in this study, a simple, sensitive and precise HPLC method was developed to estimate Saxagliptin (SG) and Enalapril (EP) from sustained-release lipospheres choosing acetonitrile, methanol and buffer in a ratio of 40 : 40 : 20 as mobile phase. Box-Behnken Design was used to study the impact of flow rate, detection wavelength and mobile phase pH on retention time and tailing factor of both drugs. A 10 µL injection volume at a flow rate of 1 mL/min under a column pressure of 1400 psig with at a detection wavelength of 212 nm was run for 08 min. The optimized retention time for EP and SG was observed as 2.12 and 4.07 min respectively whereas the tailing factor for EP and SG were found to be 1.26 and 1.56 respectively. The method was validated as per ICH guidelines where correlation coefficients (R²) for SG and EP were found to be 0.9989 and 0.9995 respectively in linearity analysis and % RSD for interday and intraday precision was observed < 2%. The average % recovery of drugs was found to be 98.92% while lipospheres assay showed 98.91% EP and 99.89% SG contents. The LOD for EP and SG was found to be 0.006 µg/mL and 0.012 µg/mL and LOQ was observed as 0.22 µg/mL for EP and 0.25 µg/mL for SG respectively. The % RSD for system suitability was also < 1% for both drugs. The developed method proved itself rapid, cost-effective, and accurate in detecting SG and EP from the selected formulation. [ABSTRACT FROM AUTHOR] |
|
Copyright of Acta Poloniae Pharmaceutica is the property of Polish Pharmaceutical Society and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Complementary Index |
