Drug and Excipient Compatibility Study of Selected B Blockers

Abstract

The study of drug–excipient compatibility represents an important phase in the preformulation stage for the development of all dosage forms. Potential physical and chemical interactions between drugs and excipients can affect the chemical nature, the stability and bioavailability of drugs and their therapeutic efficacy and safety. A present study was conducted to investigate compatibility of β blockers drugs like (Atenolol, Labetalol hydrochloride, Bisoprolol fumarate, Metoprolol succinate, Carvidilol and Propranolol hydrochloride) with the pharmaceutical excipients of povidon. The binary mixture ( 1:1) of β blockers with the excipients were stored for the duration of 6 month with an interval of 1 month. At 40°c and 75% RH and determine of drug content in sample using HPLC. Decrease in peak area of respective drug with the excipient. The quantitative and qualitative persistence of β blockers drugs in a povidone form in the presence of degradation products. The binary mixture of product is exhibited to oxidative stress condition, and the stressed sample is analyzed with the technique of high performance liquid chromatography (HPLC). The impurity profile of ATN, BPL, CRV and LBH, MS, PRP was compared with oxidative degradation profile in presence of Hydrogen peroxide and it was found similar which indicates that degradation of β blockers is due to the organic peroxide content present in excipient povidone as an impurity in it. The study exposed that Povidone was incompatible with atenolol, bisoprolol fumarate, Carvedilol, Labetalol hydrochloride. Results obtained were supporting the hypothesis. Impurities generated were beyond the identification threshold specified in ICH Q3A (R1) so it can further be qualified and characterized by suitable analytical techniques.