Comparative stability studies of fixed dose combinations of propranolol hydrochloride and flunarizine dihydrochloride by RP-HPLC

Verriboina, Sudheer Kumar and Patel, Krutika and Vasantharaju, SG and Muddukrishna, BS (2018) Comparative stability studies of fixed dose combinations of propranolol hydrochloride and flunarizine dihydrochloride by RP-HPLC. Latin American Journal of Pharmacy, 37 (12). pp. 2448-2457. ISSN 0326-2383

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Abstract

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.

Item Type: Article
Uncontrolled Keywords: Degradation; flunarizine dihydrochloride; fixed-dose combinations; propranolol hydrochloride; RP-HPLC; simultaneous.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Library
Date Deposited: 02 Jan 2019 06:26
Last Modified: 02 Jan 2019 06:26
URI: http://eprints.manipal.edu/id/eprint/152609

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