| DOI: https://doi.org/10.14456/mujps.2015.11 | Pharm Sci Asia 2015; 42(2), 85-92 |
Validation of analytical method for captopril extemporaneous preparations by high performance liquid chromatographyJ. Leanpolchareanchai, J. Suksiriworapong*
- Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand Center of Excellence in Innovative Drug Delivery and Nanomedicine, Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand
Captopril is commonly used in pediatric patients suffered from hypertension or heart failure. The most convenient and easiest dosage form for administration to these patients is liquid formulation. However, the captopril liquid formulation is not available in the market owing to the instability issue of captopril in liquid media. To accurately and precisely measure the amount of captopril in liquid formulations, the analytical method must be validated. According to the United States Pharmacopeia (USP), the captopril bulk materials and tablet can be quantified by high performance liquid chromatography (HPLC). Therefore, this study adopted the system stated in USP and illustrated the HPLC performance for the analysis of captopril in extemporaneous vehicle. The result found that the appropriate mobile phase consisted of 47% v/v methanol and 53% v/v water containing 0.1% phosphoric acid. From HPLC chromatograms, the retention times of captopril and captopril disulfide were 5.1-5.4 and 12.2-12.9 min, respectively. The linearity was observed over the concentration range of 0.75-20 ?g/mL with R2 of 0.9995. The results confirmed that the system precisely and accurately measured the amount of captopril in vehicle with %RSD less than 2% and %recovery in the range of 97.4-99.8%. The stress test indicated that the HPLC system could distinguishably separate the captopril peak from other degraded products and excipients. Hence, this modified HPLC system could be further used for the chemical stability study of captopril extemporaneous preparations.
Keyword:
Captopril, Extemporaneous preparation, HPLC analysis, Method validation
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