A validated Stability-indicating High Performance Liquid Chromatographic Method for Darunavir Ethanolate in Tablet Dosage Form
PharmaTutor (September- 2014)
ISSN: 2347 - 7881
(Volume 2, Issue 9)
Received On: 02/07/2014; Accepted On: 08/07/2014; Published On: 01/09/2014
AUTHORS: Palak G. Chaudhary1*, Bhavini N. Patel1, Chhagan N. Patel2
1Department of Quality Assurance,
2Department of Pharmaceutical Chemistry
Shri Sarvajanik Pharmacy College, Mehsana, Gujarat, India.
High performance liquid chromatographic method was developed and validated for the determination of Darunavir Ethanolate in tablet dosage form. The method was carried out on a Phenomenex luna C18 Column (150 × 4.6 mm id, 5µ) maintained at 30oC. The mobile phase consisted of water-acetonitrile (60 + 40, v/v) pumped at a flow rate 1.0 mL/min. Photo diode array detection was at 265 nm. The chromatographic separation was obtained with a retention time of 11.8 min, and the method was linear in the range of 1-30 µg/mL (r2 = 0.9997). The specificity and stability indicating capability of the method was proven through forced degradation studies, which also showed that there was no interference of the excipients. The method was validated for linearity, precision, accuracy, robustness, specificity, limit of detection and limit of quantitation. The developed method, after being validated was successively applied to the analysis of tablet formulations. The drug could be effectively separated from different degradation products and hence the method can be used for stability analysis.
How to cite this article: PG Chaudhary, BN Patel, CN Patel; A validated Stability-indicating High Performance Liquid Chromatographic Method for Darunavir Ethanolate in Tablet Dosage Form; PharmaTutor; 2014; 2(9); 91-100