A stability indicating RP-HPLC method was developed for the simultaneous estimation of propranolol hydrochloride and flunarizine dihydrochloride in bulk and various fixed-dose combinations in the presence of its degradation products. The validation of the method was performed as per ICH Q2(R1) and USFDA guidelines. The separation was achieved with a C18-Hibar column at 25 °C, mobile phase containing methanol and 25 mM ammonium formate buffer (pH adjusted to 3.8 with formic acid, 0.1% v/v Triethylamine) (75:25 v/v) at a flow rate of 1 mL/min using Photo Diode Array (PDA) detector at 238 nm. The impacts of pH-dependent hydrolysis (acidic and basic), oxidative stress, thermal stress and photolytic stress conditions on percentage degradation of both drugs were compared in bulk drug and various fixed-dose combinations. The proposed method was found specific, sensitive, and reproducible for routine analysis of propranolol hydrochloride and flunarizine dihydrochloride fixed-dose combinations within 10 min as run time.
|Number of pages||10|
|Journal||Latin American Journal of Pharmacy|
|Publication status||Published - 01-01-2018|
All Science Journal Classification (ASJC) codes
- Pharmaceutical Science
- Drug Discovery