STABILITY PROFILE DEVELOPMENT USING SIMULTANEOUS ESTIMATION METHOD FOR FIXED DOSED COMBINATION OF ALISKIREN AND AMLODIPINE BY HPLCAbstract
The Pharma market is getting flooded with fixed dose combination drugs due to better patient compliance, has but created a challenging situation for analytical chemists. The objective of study was developing an analytical method for simultaneously estimating aliskiren and amlodipine in combination with their forced degradation products obtained by treating the sample under tress conditions like acid and base hydrolysis (0.01N HCl, and 0.01 NaOH, oxidation(3% H2O2), photolytic and thermal degradation(80oC). The linearity ranging was 2.5-25μg/ml and 10-100μg/ml of Amlodipine and Aliskiren and regression coefficient was found to be 0.998 and 0.996 respectively. The chromatographic separation of analyte was carried out using JASCO HPLC system with HiQ Sil C8 (4.6mmØ × 250mm, 5 𝜇) column. The mobile phase consists of acetronitrile and pH was adjusted to 4 with orthophosphoric acid solution. The analyte were detected at 210nm using UV detector with flow rate of 1ml/min.
S. Choudhari, S. A. Pishawikar *, S. G. Killedar and H. N. More
Bharati Vidyapeeth College of Pharmacy, Kolhapur, Maharashtra, India.
15 August, 2017
12 November, 2017
17 November, 2017
01 June, 2018