TY - JOUR
T1 - Comparative stability studies of fixed dose combinations of propranolol hydrochloride and flunarizine dihydrochloride by RP-HPLC
AU - Verriboina, Sudheer Kumar
AU - Patel, Krutika
AU - Vasantharaju, S. G.
AU - Muddukrishna, B. S.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
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M3 - Article
AN - SCOPUS:85060919589
SN - 0326-2383
VL - 37
SP - 2448
EP - 2457
JO - Latin American Journal of Pharmacy
JF - Latin American Journal of Pharmacy
IS - 12
ER -