Spectrofluorimetric determination of Bisoprolol fumarate and Rosuvastatin calcium in a novel combined formulation and in human spiked plasma

Abstract

Sensitive, simple and rapid spectrofluorimetric method was developed for simultaneous determination of bisoprolol fumarate (BIS) and rosuvastatin calcium (ROS) in novel formulated tablets and in human spiked plasma depending on measuring their native fluorescence. The fluorescence intensity of BIS and ROS were measured in methanol at emission wavelength of 297 and 485 nm upon excitation at 227 and 242 nm, respectively. The emission spectrum of each drug reveals zero value at the emission wavelength of the other drug, thus allowing their simultaneous determination without any interference and without using any tedious derivatization steps. Excellent linearity was obtained over the range of 10-500 and 20-1000 ng/mL for BIS and ROS, respectively. The developed method was evaluated by applying to laboratory prepared mixtures and pharmaceutical formulation. The high sensitivity of the method was the motivation to its application for analysis of the cited drugs in spiked human plasma. Likewise, analytical and bioanalytical method validation was carried out following International Conference on Harmonisation guidelines and also statistical analysis with the reported methods was carried out and no significant difference was found. The developed method is the first developed spectrofluorimetric method for simultaneous determination of the newly formulated drugs.

Simultaneous determination of bisoprolol fumarate and rosuvastatin calcium in a new combined formulation by validated RP-HPLC

“…All chemicals and solvents used throughout this work were of analytical grade and were used without further purification such as methanol; acetonitrile were HPLC grade (SDS, France), while orthophosphoric acid and deionized water were purchased from El-NASR Pharmaceutical Chemicals Co., Abu-Zabaal, Cairo, Egypt. For tablets formulation, the used Avecil PH 101, pharmaburst, aerosil, magnesium stearate, and lactose monohydrate were purchased from Sigma-Aldrich Company, Egypt [5].…”

“…The tablets were formulated using, the pure drugs, Avecil PH 101, Pharmaburst, Aerosil, magnesium stearate, and lactose monohydrate with suitable ratios to get the final tablet weight 150 mg according to reference [5]. By using mortar and pestle, the calculated amounts of the drug and excipients were mixed then the calculated amount of magnesium stearate was added.…”

“…This combination was the invention related to Bondjers et al [4] as The literature survey revealed that no any chromatographic method was reported for the simultaneous estimation of BIS and ROS in combination. While only one spectrofluorimetric method was found for their determination in those tablets [5]. On the other hand, determination of each drug was reported either alone or in other combinations.…”

Development and validation of RP-HPLC method for simultaneous estimation of rosuvastatin and bisoprolol fumarate in bulk and formulations

“…Bisoprolol is also an antihypertensives agent with a chemical formula of C18H31NO4, chemically it is 1-(propan-2-ylamino)-3-[4-(2-propan-2-yloxyethoxymethyl) phenoxy] propan-2-ol 2 . Bisoprolol was analyzed alone or in combination with other drugs using, RP-HPLC [3][4][5][6][7][8] , UV-Spectroscopic [9][10][11] , voltametric 12 , UPLC 13 , methods. Literature survey revealed analytical methods like, RP-HPLC [14][15][16] , LC-MS-MS [16][17] UPLC 18 for analysis of Rosuvastatin individually and in combination with other drugs.…”

First derivative synchronous spectrofluorimetric analysis of bisoprolol fumarate and ivabradine in pharmaceutical and biological matrices. Investigation of the method greenness

“…[1] The British Pharmacopoeia (BP) suggested nonaqueous potentiometric titration for the assay of BSF in raw materials, [14] whereas the United States Pharmacopeia (USP) recommended high-performance liquid chromatography (HPLC) with ultraviolet (UV) light detection for its analysis. [15] The published literature revealed various analytical methods for the analysis of BSF such as spectrophotometry, [16][17][18] spectroflourimetry, [19] electrochemical methods, [20][21][22][23] HPLC, [24][25][26][27] and LC-MS/MS. [28] A combination of IVA and BSF is used for patients with stable angina and for patients with systolic heart failure that results in additional anti-ischaemic and antianginal effects.…”