An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker

BF is Beta-adreno receptor antagonist and used as an AntiHypertensive Drug. BF gives the blocking action on β1-adrenergic receptors in the heart and vascular smooth muscle. The present review compiles the various approaches implemented for quantification of BF in bulk drug, pharmaceutical matrix and biological fluid. This review represents more than 50 analytical methods which include capillary electrophoresis, HPLC, HPTLC, UV-Spectroscopy, UPLC, impurity profiling and electrochemical methods implemented for estimation of BF as a single component as well as in multicomponent. Keyword: BF; Bioanalytical; UPLC/LC-MS; capillary electrophoresis; impurity profile


INTRODUCTION
BF is an extremely discriminatory β1-adrenergic blocker [1]. Figure 1. It is official in, USP. BF has similar structure to metoprolol, bopindolol, hydrochlorothiazide, atenolol [2]. Structure of BF, there is two substituents at para position of benzene provide the activity of β-selectivity, In which it has two substituents in para position of benzene which might be the activity of βselectivity [3]. White crystalline powder of BF was soluble in water, methanol, ethanol, and chloroform. [4]. BF blocks catecholamine stimulus of β1-adrenergic receptors in the heart (cardio-selective) and

PHARMACOPOEIAL STATUS
BF is the official drug in the (USP29) united state of pharmacopeia (2004). USP reported HPLC assay method using 4.6 mm × 12.5 cm column that contain packing L7 as a stationary phase and a mobile phase consist mixture of (65:35 % v/v). Water-acetonitrile used as diluents to 1 L portion add 5 mL heptaflurobutyric acid, 5 mL diethyl amine and 2.5 mL formic acid with flow rate 1 mL/min, the column outflow was scan at 273 nm [8]. Tablet Patients with renal impairment: Not exceed 10 mg once daily.

Tablet
Patients with severe liver impairment: No dosage adjustment is required, however careful monitoring is advised.

Tablet
The maximum recommended dose is 10 mg once daily. Elderly: No dosage adjustment is normally required. It is recommended to start with the lowest possible dose. Children: There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.

UV/VIS-SPECTROPHOTOMETRIC METHODS OF BF [9 -20]
In article about nine UV-Spectrophotometric methods have been fixed for assurance of BFsingle and in combination of different dosage form. Also one spectroflurometric method has been accounted for determination of BF. The detailed summary spectrophotometer and spectroflurometer designating the basic principle, sample matrix, linearity and retention time in Table 2. It is depend on charge transfer reaction between the designed drugs and 7-Chloro-4-nitrobenzen-2-oxa-1; 3-diazole NBD-CI. Dilution was prepared by using specific volume of NBD-CI (0.1%, w/v).By using 5 mL with acetonitrile it get heated and after cooling the fusion of solution was attenuate to 10 mL with acetonitrile and methanol for IRB and BHF, respectively. The absorbance was recorded at 476 and 479 for IRB and BHF, at colored concentration respectively against the reagent blank treated similarly. The linearity was obeyed in the range of 2.5-8 μg/mL for IRB and 6-16 μg/mL for BHF. This method also gives detection limits of 0.18 and 0.39μg/mL and a secondary quantification limit of 0.55 and 1.17μg/mL for IRB and BHF.
The statistical evaluation of the results with the results of reported methods reflected that there was no major differentiation [16].

CHROMATOGRAPHIC SYNOPSIS 6.1 High-Performance Liquid-Chromatography [21-42]
Distant from Pharmacopoeial methods many HPLC methods were accounted for assurance for BF in pharmaceutical formulation. The outlined of expressed HPLC methods specifically the mobile phase used for estimation, columns, wavelength, correlation coefficient and linearity range is shown in the Table 3.  ) reported an enantiomer separation of BF by TLC and HPTLC by means of (+)-10-camphorsulphonic acid as a chiral selector. Chromatographic separation of BF was performed with optically pure (+)-10-camphorsulphonic acid as a chiral selector. The mobile phase set for separation was triethyl amine-methanol-1-pentanol (0.14:9.9:0.18, %v/v/v). For TLC detection was executed at UV-chamber at short wavelength 254 nm and for HPTLC densitometry detection performed at 224 nm. The calibration ranges for both the isomers were 5-30 μg/mL [45].

STABILITY-INDICATING METHODS (SIM) FOR ESTIMATION OF BF [46-51]
With reference four stability indicating methods studied accordingly for persistence of BF in bulk substance and pharmaceutical dosage form implementing several analytical techniques. The reported stability indicating methods for BF illustrating dosage form, column, mobile phase and linearity and retention factor presented in [Table: 4]. In that developed method, capillary electrophoresis fixed with tris (2, 2'-bipyridyl)-ruthenium (II) electrochemiluminescence for the estimationas well asillustrates relationship between the METO T and BF and human serum albumin. There are different parameters were selected for optimization of CZE separation; because they affect the CZE separation and ECL detection, the optimized parameters like pH, amount of running buffer, detachment voltage and potential exposures. Under enhanced condition METO T and BF were well separated and identified within 10 min [53].
Jingwu Wang et al. (2008) illustrate daspeedy, selective, and responsive capillary zone electrophoresis (CZE) attached through tris (2,2-bipyridyl) ruthenium(II)-based end-column electrogenerated chemiluminescence (ECL) was utilized to estimate BF in bulk and tablets subsequent to its separation from METO. Tetrahydrofuran were used as an additive in the running buffer to receive the absolute ECL peak of BF. It react with tris (2, 2-bipyridyl) ruthenium (II) ECL system. Under the advanced experimental situation, BF was separated successfully and efficiently from METO and other co-existed materials in tablets and urine samples [54].

DETERMINATION OF BF [56-67]
Bioanalytical methods are used for the quantitation of drugs and their metabolites and biological molecule in unnatural location or concentration) and biotic (macromolecule, large molecule drugs and metabolites) in organic systems [56]. Literature survey revealed that LC-MS/MS and HPLC and are predominantly used for the bioanalysis of BF. In Bioanalytical method validation sample is extracted from plasma with help of extraction techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction techniques. In most of methods methanol was used as solvent for extraction of BF in biological fluids. Bioanalytical methods for determination of BF are summarized in [Table: 5].

IMPURITY PROFILING ON BF [68-72]
The impurity profiling is designed with objectives to establish specific link between two or more samples, ascending drug distribution pattern, for identification of sources of drug samples and also for monitoring the process for drug manufacturing [68]. According to the ICH guidelines impurities are matter in the product which is not active pharmaceutical ingredients or the excepient used to manufacture it [69].An impurity profile has been established for quantification of BF alone and in combined dosage form. There are a various types of impurities present in BF. Following explanation can be established the impurity present in BF and their combined dosage form.      study of BF and its impurities A and C. The chemometric strategy was resolved to systems activities and establishing the mathematical association between acetonitrile content which was present in mobile phase, pH of the water phase and buffer concentration in the water phase and chromatographic responses. Investigation all studies of BF from beginning to end Chromatographic technique and its impurities was established on HILIC 100Å (100 mm x 4.5 mm, 2.6 µm particle size); using mobile phase mixture consist was acetonitrile -water phase (35 mM ammonium acetate, pH 4.9 manage with glacial acetic acid) (85:15 v/v) with flow rate 1 mL/min and analysis was performed at ambient temperature. Impurities of BF (impurity A and impurity C) are shown in Table 6 [70].
Ivana  established identification, structural interpretation and qualification of a degradation impurity RRT 0.95 of BF in film-coated tablets. The impurity of relative retention time gives at 0.95 was observed in the stress thermal degradation study of the BF film-coated tablets with identification, characterization and quantitation was performed using HPLC/DAD/ESI-MS method. The configuration of the embattled Impurity RRT 0.95 was shown in Table 6 with molecular mass of BF were 406 [71].
Venkata Narasimha Rao  studied twelve impurities of BF and HCT and separated simultaneously using HPLC technique. Out of 12 reported impurities, five were found to be potential degradants. During the validation of stability indicating method, the focus was on the critical parameters in resolving the degradants from the main components. These parameters include Hand, temperature solvents because BF and HCT have different solubilities and polarities. The method was precise (RSD<1.0%), accurate, linear (r2>0.999), robust, and stability indicating in the range of LOQ to 150% [72].

Voltammetric methods for BF: [73-75]
Rajendra N. Goyal et al.(2011) recognized an voltammetric performance of BF by using graphite electrodes were completed with single wall carbon nanotubes. In comparison to BPPGE, EPPGE gives supplementary sharp peaks in oxidation of BF. In the variety 10 -1000 mV/s in phosphate buffer solution of pH 7.2, the examination rate of repeated voltammogram was assorted. The limits of detection were found to be 2.8 × 10 -7 M and 7.3 × 10 -7 M [73]. Bozal et al (2012) wasreported Simultaneous estimation of BF and HCT in their pharmaceutical formulation by applying different voltammetric, chromatographic, and spectrophotometric analytical methods. The level of difference pulse and square wave voltammetry techniques were used for the analysis of BF and HCT concurrently by measuring at with reference to 1400 and 1100 mv. By using different electrolytes including H 2 SO 4 , phosphate, acetate, and BR buffers with different pH values between 0.3 and 12.0 containing a constant amount of 20% methanol the voltammetric oxidation of BF and HCT were reported. BF was oxidized between pH 0.3 and 10.
Rajendra N. Goyal et al. (2007)studied a BF in pharmaceutical dosage form and urine using single-wall carbon nano tubes customized glassy carbon electrode. The SWNTs-modified GCE exhibited a sharp anodic peak at a potential of 950mV for the oxidation of BF. In good condition linearity was found in the range of 0.01-0.1mM in 0.5M phosphate buffer solution having pH 7.2 with a correlation coefficient of 0.9789 and limit of detection was reported at 8.27 × 10 −7 M.

Potentiometric method for BF: [76-77]
Grzegorzbazylak et al. (2002) reported execution of analytical and biopharmaceutical screening data for beta-adrenergic-drug simple menting many macro cycle in HPLC Systems. In the cation-exchange HPLC technique for the studies applying acetonitrile -40 mM phosphoric acid (15: 85,% v/v,) as a mobile phase. By employing crossbreed polymer silica packets in RP-HPLC it can be considered that promising surrogate in high throughput drug control process for examination of beta adrenergic agonist in humans and animals recommend the Potentiometric recognition [76].
Saad S.M. Hassan et al. (2003) reported the used of polymeric medium membrane sensors for purpose of β-blockers. This sensor was depending on the cations with tungs to phosphate anion as electro active materials. In some dosage form sensors are implemented for direct potentiometry of β-blockers. for the construction of the sensor plastic membrane can be made by preparing composition 2:34:64% (w/ w) ion pair complex, PVC and DOP plasticizer. The sensor was uncomplicated for the purpose of b-blockers at a concentration level as low as 10 -7 mol l -1 with an accuracy of 99.1 ±/1.3 %. [77].

CONCLUSION
The present review gives various analytical methods for the estimation of BF. A different analysis had perform which include, Bio-analytical, HPLC, HPTLC, UV/Vis-Spectroscopy, Spectroflurometry, capillary electrophoresis, stability indicating method, impurity profile and electrochemical method like voltammetric and Potentiometric method for validation of BF in bulk and in Dhandar its combined pharmaceutical formulations and in plasma. Through HPLC with UV detection has been found to be most studied for estimation of BF in bulk as well as pharmaceutical dosage forms, while hyphenated LS-MS, Bioanalytical, UPLC methods are reported for quantification of BF and its metabolite in plasma and other biological fluids. HPTLC and Stability-indicating by HPLC and HPTLC are also reported in literature survey. Certain Spectrophometric methods in UV-Visible along with spectroflurometric are most often used for assessment for BF. Various types of stability indicating method and impurity profiling method have been estimated.