1 Department of Quality Assurance, Khyati College of Pharmacy, Palodiya, Ahmedabad.
2 Department of Pharmaceutics, School of Pharmacy, Dr. Subhash University
The accurate estimation of active pharmaceutical ingredients (APIs) is essential in ensuring the safety, efficacy, and quality of pharmaceutical products. This review presents a comprehensive analysis of various analytical methods developed for the estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate, both as individual components and in combination. Dapagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, and Bisoprolol, a ?1-selective adrenergic blocker, in combined fixed dosage form are included in CDSCO approval latter for conduct of clinical trial. The combination is administered for the condition of Heart Failure with Reduced Ejection Fraction (HFrEF). The review covers analytical techniques including high-performance liquid chromatography (HPLC), and liquid chromatography–mass spectrometry (LC-MS). Emphasis is placed on method development, validation parameters in accordance with ICH guidelines, and the applicability of these methods in pharmaceutical formulation analysis. This compilation serves as a valuable resource for researchers and analysts involved in drug quality control, formulation development, and regulatory compliance.
Analytical chemistry deals with identification of components (qualitative) and determination of quantity of components (quantitative) of substances or samples or mixture.
Figure 1: Types of Analytical Chemistry
Categories of Analytical techniques:
A. Chemical - Chemical procedures involve basic glassware manipulation and chemical Processes.
B. Instrumental Techniques - Instrumental approaches use intricate instruments for energy quantification and sample makeup.
Analytical method includes use of a specified technique and detailed-stepwise instructions which are used in qualitative, quantitative or structural analysis of a sample for one or more analytes.
Figure 2: Classification of Analytical Methods
Analytical Method Development [3-6]
Analytical method development is the process of selecting and optimizing analytical methods to measure a specific attribute of a drug substance or drug product. It’s a systematic approach to evaluate and select suitable methods that are sensitive, specific, and robust. Analytical methods are used to measure the target attribute within acceptable limits of accuracy and precision. This shows that analytical procedures are adequate for the purpose of assessing drugs. If a new method is being developed then it should be fitted in GMP and GLP environments. It must be developed using the protocols and acceptance criteria set out in the ICH guidelines Q14 and Q2(R2).
Heart Failure with Reduced Ejection Fraction (HFrEF)[7,8]
HF is a clinical syndrome arising from functional or structural impairment in the filling &/or ejection of blood by the ventricles. In case of HFrEF, left ventricular ejection fraction is 40% or less.
Etiology:
Pharmacological agents available for the treatment of HFrEF:
Drug Profile of Bisoprolol Fumarate:
|
IUPAC Name |
(2E)-but-2-enedioic acid; bis(1-[(propan-2-yl)amino]-3-(4-{[2-(propan-2-yloxy)ethoxy]methyl}phenoxy)propan-2-ol) |
|
Molecular Formula |
(C18H31NO4)2 ? C4H4O4 |
|
Chemical Structure |
|
|
Molecular Mass |
767.0 g/mol |
|
Description |
White crystalline powder |
|
Solubility |
Very soluble in water and in methanol; freely soluble in chloroform, in glacial acetic acid, and in alcohol; slightly soluble in acetone and in ethyl acetate. |
|
pH and pKa Value |
pH of a 1% solution: 6.0 and 7.0 9.59 |
|
Melting Point |
pH of a 1% solution: 6.0 and 7.0 |
|
CAS No. |
104344-23-2 |
|
Mechanism of Action |
Bisoprolol Fumarate is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure and congestive heart failure. It has negative inotropic and chronotropic effects; decrease heart contractions and heart rate. As a result, bisoprolol reduces the oxygen consumption of myocardial cells. β1 receptors are also present in the juxtaglomerular cells. By blocking these receptors, bisoprolol leads to a decrease in the release of renin; as a result, this decrease in renin blocks the activation of the renin-angiotensin system. |
Drug Profile of Dapagliflozin Propanediol Monohydrate:
|
IUPAC Name |
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol |
|
Molecular Formula |
C21H25ClO6 |
|
Chemical Structure |
|
|
Molecular Mass |
408.9 g/mol |
|
Description |
White to off-white, crystalline, non-hygroscopic powder |
|
Solubility |
Soluble in ethanol (95 per cent), slightly soluble in water and practically insoluble in hexane |
|
Dissosiation Constant pKa |
7.2 |
|
Melting Point |
72.4°C to 76.1°C |
|
CAS No. |
461432-26-8 |
|
Mechanism of Action |
Dapagliflozin is a derivative of naturally occurring dihydrocholine glucoside. It acts as a sodium-glucose cotransporter 2 (SGLT-2) inhibitor. In addition to clinical efficacy in type 2 diabetes, evidence from clinical trial suggests that dapagliflozin is of benefit in treating heart failure with or without type 2 diabetes as a comorbidity. |
Official Methods of Bisoprolol Fumarate:
|
Pharmacopoeia |
Details |
Ref |
|
Indian Pharmacopoeia (IP) 2018 |
RP-HPLC Column: A stainless-steel column 12.5 cm x 4.6 mm, packed with octylsilane bonded to porous silica (5 µm) M.P.: 100 volumes of the solvent mixture, 0.5 volumes of heptafluoro butyric acid, 0.5 volumes of diethylamine and 0.25 volumes of formic acid. Detection wavelength: UV- 273 nm Flow Rate: 1.0 mL/min |
19 |
|
United States Pharmacopoeia (USP) 2024 |
RP-HPLC Column: 4.6-mm × 12.5-cm; packing L7 Diluent: water and acetonitrile (65:35) M.P.: 1-L portion of Diluent add 5 mL of Standard solution: 1 mg/mL of USP Bisoprolol Fumarate RS heptafluorobutyric acid, 5 mL of diethylamine, and 2.5 mL of in Diluent formic acid. Mode: LC Detection wavelength: UV - 273nm Flow Rate: 1.0 mL/min |
20 |
|
European Pharmacopoeia (EP) 2023 |
RP-HPLC Column: 4.6-mm × 12.5-cm; packing L7 Diluent: water and acetonitrile (65:35 %v/v) M.P.: heptafluorobutyric acid, 5 mL of diethylamine, and 2.5 mL of in Diluent formic acid. Mode: LC Detection wavelength: UV - 273nm Flow Rate: 1.0 mL/min |
21 |
|
British Pharmacopoeia (BP) 2018 |
RP-HPLC Column: 4.6-mm × 12.5-cm; packing L7 Diluent: water and acetonitrile (65:35%v/v) M.P.: 1-L portion of Diluent add 5 mL of Standard solution: 1 mg/mL of USP Bisoprolol Fumarate RS heptafluorobutyric acid, 5 mL of diethylamine, and 2.5 mL of in Diluent formic acid. Detection wavelength: UV - 273nm Flow Rate: 1.0 mL/min |
22 |
Reported Methods of Bisoprolol Fumarate:
|
Title |
Name of Journal with year of Publication |
Summary |
Ref. No. |
|
Development and Validation of RP-HPLC Method for Estimation of Bisoprolol Fumarate In Bulk and Tablets |
Journal for Pharmaceutical, Chemical Sciences and Ayurveda, 2024 |
RP-HPLC Column: Fortis RP C18 column (250 mm ×4.6 mm) 5µm M. P.: Methanol: Water (80:20) pH adjusted to 8 with triethylamine Mode: Gradient Detection wavelength: 230 nm Flow Rate: 1.0 ml/min RT BSL: 6.312 min |
23. |
|
Development and Validation of Analytical Method for Estimation of Bisoprolol Fumarate in Bulk and Solid Dosage Form by RP HPLC |
International Journal of Pharmaceutical Research and Applications, 2023 |
RP-HPLC Column: Shimadzu make RP 18 analytical column (250 mm × 4.6 mm i.d., 5.0 μm) M. P.: Acetonitrile: Water with pH 3.0 (70:30 %v/v) Mode: 224 nm Detection wavelength: Flow Rate: 0.80 ml/min RT BSL: |
24. |
|
Design of Optimized RP-HPLC Method for Quantitative Analysis of Bisoprolol Fumarate in Bulk and Pharmaceutical Dosage Form |
Scholars International Journal of Chemistry and Material Sciences, 2023 |
RP-HPLC Column: Reprosil pure basic C18 M. P.: Acetonitrile : Potassium dihydrogen phosphate buffer (0.050 mol/L) (30:70 %V/V), pH 3.5 (adjusted with phosphoric acid Mode: Isocratic Detection wavelength: 233 nm Flow Rate: 1.0 ml/min RT BSL: 5.7 min RT Telmisartan: 7.6 min |
25 |
|
An Insight on Analytical Profile on Bisoprolol Fumarate – A Selective Beta-1 Adrenoreceptor Blocker |
Journal of Pharmaceutical Technology, Research and Management, 2017 |
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 |
26 |
|
Quantitative Determination of Bisoprolol Fumarate by HPLC |
Revista de Chimie, 2016 |
Column: Eclipse XDB C18 (150 mm x 4.6 mm, 5 m) M. P.: Water: Methanol: Acetonitrile (50:30:20 %v/v) Mode: Isocratic Detection wavelength: 225 nm Flow Rate: 1.0 ml/min |
27 |
|
Development And Validation of Rp-Hplc Method for The Determination of Bisoprolol Fumarate Tablets |
International Journal of Research in Pharmaceutical and Nano Sciences, 2013 |
RP-HPLC Column: prontosil, chromo bond, C18, (250X4.6) mm, 5µ M. P.: buffer (pH 5.6): Acetonitrile (75:25 %v/v) Mode: Isocratic Detection wavelength: 226 nm PDA detector Flow Rate: 1.0 ml/min RT BSL: 9.15 min |
28 |
Reported methods of Bisoprolol Fumarate in combination with other drugs:
|
A Novel Analytical Method for Simultaneous Quantification of Bisoprolol and Cilnidipine by Reversed-Phase HPLC in Pure and Tablet Dosage Form |
Biomedical and Pharmacology Journal, 2025 |
Column: Waters X Terra (150x4.6mm; 3.5µm) M. P.: Acetonitrile: 0.1% trifluoroacetic acid (60:40%v/v) Mode: Isocratic Detection wavelength: 225 nm Flow Rate: 1.0 ml/min RT BSL: 3.129min RT Cilnidipine: 6.925min |
29 |
|
Development and validation of RP-HPLC method for simultaneous estimation of rosuvastatin and bisoprolol fumarate in bulk and formulations |
International Journal of Health Sciences, 2022 |
Column: C18 column M. P.: Methanol: Phosphate buffer (pH 3.5) 45:55% V/V Mode: Isocratic Detection wavelength: 245 nm Flow Rate: 1.0 ml/min RT BSL: 1.50 min RT Cilnidipine: 2.31 min |
30 |
|
Stability-indicating RP-HPLC method development and validation for simultaneous estimation of bisoprolol fumarate and amlodipine besylate in bulk and in tablet dosage form |
Journal of Applied Pharmaceutical Science, 2021 |
RP-HPLC Column: Oyster ODS3 (150 × 4.6 mm, 5 µm) M. P.: Phosphate buffer with pH 2.5 (adjusted by 5% orthophosphoric acid):Methanol:Acetonitrile (42:29:29 %v/v/v) Mode: Isocratic Detection wavelength: 230nm Flow Rate: 1.0 ml/min RT BSL: 2.543 nm RT Amlodipine: 4.883 nm |
31 |
|
Development and validation of a fast and simple HPLC method for the simultaneous determination of bisoprolol and enalapril in dosage form |
Pharmacia, 2021 |
RP-HPLC Column: Zorbax Rx C8 250x4.6mm, 5um M. P.: Water: Methanol: 0.07% perchloric acid (55:45 %v/v) Mode: Isocratic Detection wavelength: 214 nm Flow Rate: 1.0 ml/min RT BSL: 4.7 min RT Enalapril: 5.2 min |
32 |
|
RP-HPLC Method Development and Validation for Simultaneous Estimation of Bisoprolol Fumarate and Cilnidipine in Pharmaceutical Dosage Form |
Journal of Pharmaceutical Science and Bioscientific Research, 2020 |
RP-HPLC Column: (C18) Inertsil ODS 3V column (150*4.6mm,5µm) M. P.: Buffer (0.1% Formic acid in water): Methanol (20:80 %v/v) Mode: Isocratic Detection wavelength: 231nm Flow Rate: 1.0 ml/min RT BSL: 2.84min RT Enalapril: 1.518min |
33 |
|
HPLC method development for the analysis of bisoprolol in combined dosage form containing bisoprolol and enalapril and in vitro dissolution studied |
International Journal of Applied Pharmaceutics, 2019 |
Column: Hi Qsil C18 (5 μm, 4.6?250 mm) M. P.: Methanol: phosphate buffer solution (65:35, v/v) Mode: Isocratic Detection wavelength: 225 nm Flow Rate: 1.0 ml/min RT BSL: 4.75 min |
34 |
|
RP-HPLC Method Development and Validation for Simultaneous Estimation of Cilnidipine and Bisoprolol Fumarate in Tablet Dosage Form |
International Journal of ChemTech Research, 2019 |
Column: Shiseido – C18 (250*4.6mm, 5 µm) M. P.: Phosphate buffer (pH-3.5) : Methanol (60 : 40 %v/v) Mode: Isocratic Detection wavelength: Flow Rate: 1.0 ml/min RT BSL: 4.053 min RT Cilnidipine: 5.730 min |
35 |
|
Simultaneous estimation of bisoprolol fumarate and cilnidipine in tablet dosage form using RP-HPLC method |
International Journal of Pharma and Biosciences, 2018 |
Column: Agilent Eclipse plus C18 (4.6 x 100 mm) 3.5µm M. P.: Water (pH 5.6): Methanol (20:80 %v/v) Mode: Isocratic Detection wavelength: 232nm Flow Rate: 1.0 ml/min RT BSL: 1.50 min RT Cilnidipine: 2.31 min |
36 |
|
Development and Validation of Analytical Method for Simultaneous Estimation of Bisoprolol Fumarate and Telmisartan by Using RP HPLC Method |
International Journal of Pharmaceutical and Clinical Research, 2018 |
RP-HPLC Column: Waters X Bridge RP C18 (4.6 x 250 mm) M. P.: Methanol: Water (75:25 %v/v) Mode: Isocratic Detection wavelength: 231 nm Flow Rate: 1.0 ml/min RT BSL: 5.7 min RT Telmisartan: 7.6 min |
37 |
|
Validated and Stability Indicating Liquid Chromatography Method for Quantification of Bisoprolol Fumarate in Tablet Dosage Form |
International Journal of Pharmacy, 2012 |
Column: Chromo band C18 (250 x 4.6 mm, 5 μm) M. P.: Buffer: Acetonitrile (75:25 %v/v, pH 5.6) Mode: Isocratic Detection wavelength: 226 nm Flow Rate: 1.0 ml/min RT BSL: 9.50 min |
38 |
|
Simultaneous Estimation of Bisoprolol Fumarate and Hydrochlorothiazidein Tablet Dosage Form by RP-HPLC Method |
Indian Journal of Pharmaceutical Sciences, 2007 |
RP-HPLC Column: Lichrosphere 100 C-18 M. P.: Water: Acetonitrile: Tetrahydrofuran (80:20:5 %v/v) Mode: Isocratic Detection wavelength: Flow Rate: 1.0 ml/min RT BSL: 1.48 min RT Hydrochlorothiazidein: 4.72 min |
39 |
Official Methods of Dapagliflozin:
|
United States Pharmacopoeia (USP) 2024 |
RP-HPLC Column: Octadecylsilanized silica gel (C18) (250 mm ×4.6 mm) 3.5µm M.P.: Acetonitrile and Water 60:40 %v/v Detection wavelength: 245nm Flow Rate: 1.0 ml/min |
40 |
Reported Methods of Dapagliflozin:
|
Development and Validation of stability-Indicating RP-HPLC method for determination of Dapagliflozin |
Journal of Advanced Pharmacy Education & Research, 2024 |
RP-HPLC Column: BDS column M. P.: Acetonitrile and Ortho phosphoric acid (55:45%v/v) Mode: Gradient Detection wavelength: 245nm Flow Rate: 1ml/min RT DGZ: 2.873 min |
41 |
|
A New Analytical Method Development and Validation for the Estimation of Dapagliflozin by Using Reverse Phase-High Performance Liquid Chromatography |
International Journal Of Advanced Research In Medical & Pharmaceutical Sciences, 2021 |
RP-HPLC Column: Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm M.P.: Methanol : Phosphate buffer (0.02M, pH-3.6) 45:55 %v/v Mode: Isocratic Detection wavelength: 255nm Flow Rate: 1.0 ml/min RT : 3.254 min |
42 |
|
RP-HPLC Method for Estimation of Dapagliflozin from its Tablet |
International Journal of ChemTech Research, 2018 |
RP-HPLC Column: Princeton C18 M.P.: Acetonitrile: 0.1% Triethylamine (pH-5.0) (50:50%v/v) Mode: Isocratic Detection wavelength: 224nm Flow Rate: 1.0 ml/min RT : 5.163min |
43 |
|
A New RP-HPLC Method Development and Validation of Dapagliflozin in Bulk and Tablet Dosage Form |
International Journal of Drug Development and Research, 2017 |
RP-HPLC Column: Waters C18, 5 µm particle size, 25 cm × 4.6 mm M. P.: Phosphate buffer and acetonitrile (60:40 %v/v) Mode: Detection wavelength: 237 nm Flow Rate: 1ml/min RT DGZ: 3.461 min |
44 |
|
Development And Validation Of Dapagliflozin By Reversed-Phase High-Performance Liquid Chromatography Method And It’s Forced Degradation Studies |
Asian Journal of Pharmaceutical and Clinical Research, 2017 |
RP-HPLC Column: hypersil BDS (250 mm × 4.6 mm, 5 µ) M. P.: buffer:acetonitrile (60:40) Mode: Detection wavelength: 245 nm Flow Rate: 1.0 ml/min RT DGZ: 2.79 min |
45 |
Reported Methods of Dapagliflozin in combination with other drugs:
|
Analytical Method Development and Validation of Teneligliptin and Dapagliflozin API In Marketed Formulation |
International Journal of Pharmaceutical Sciences and Research, 2024 |
RP-HPLC Column: Prontosil C18 M. P.: Acetonitrile: 3.5 pH Potassium dihydrogen phosphate buffer (60:40 v/v) Detection wavelength: 227 nm Flow Rate: 1.0 ml/min RT DGZ: 3.61 min RT TNG: 2.37 min |
46 |
|
Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form |
International Journal of Drug Delivery Technology, 2024 |
RP-HPLC Column: Thermo Hypersil Gold C18 column M. P.: Acetonitrile (ACN) and water (40: 60 % v/v) (adjusted with O-H3PO4 to pH 3) Mode: Isocratic Detection wavelength: 213 nm Flow Rate: 1ml/min RT DGZ: 8.3 min RT VGL: 2.9 min |
47 |
|
Novel Analytical Method for Combined Dapagliflozin and Vildagliptin in Bulk and Pharmaceutical Dosage Form Using HPLC |
Archives of Pharmacy Practice, 2024 |
RP-HPLC Column: Agilent C18 (150 x 4.6 mm, 5 mm) M. P.: Orthophosphoric acid: Acetonitrile (pH 5) Mode: Isocratic Detection wavelength: 224 nm Flow Rate: 0.7 ml/min RT DGZ: 3.5 min RT Vidagliptin: 2.1 min (Vildagliptin) |
48 |
|
Quantitative Estimation and Validation of Dapagliflozin And Linagliptin Hydrochloride In Pharmaceutical Dosage Form By RP HPLC |
African Journal of Biomedical Research, 2024 |
RP-HPLC Column: Thermo Scientific Syncronis C8, (250 mm × 4.6 mm, 5μm) Mobile Phase: Phosphate buffer: acetonitrile (30:70 %v/v) Mode: Binary Gradient Detection wavelength: 224 nm Flow Rate: 1.0 ml/min RT DGZ: 3.3 min RT Linagliptin: 2.3 min |
49 |
|
A New Stability Indicating HPLC Method for Related Substances in Dapagliflozin |
International Journal of Drug Delivery Technology, 2024 |
RP-HPLC Column: Princeton C18 column M. P.: Acetonitrile and 0.1% Triethylamine (50:50 %v/v) Mode: Isocratic Detection wavelength: 224 nm Flow Rate: 1ml/min RT DGZ: 5.163 minutes |
50 |
|
Analytical Method Development and Validation of Dapagliflozin by RP HPLC Method in Tablet Dosage Form |
International Journal of Pharmaceutical Sciences, 2024 |
RP-HPLC Column: Inertsil ODS-3V M. P.: Acetonitrile: Water (50: 50 % v/v) Mode: Isocratic Detection wavelength: 223nm Flow Rate: 1.0 ml/min RT DGZ: 4.60 min |
51 |
|
RP-HPLC Method Development and Validation for the Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Linagliptin in Tablet Dosage Form |
African Journal of Biomedical Research, 2024 |
RP-HPLC Column: Qualisil5 BDS C18 column (250×4.6mm,5µm) M. P.: 0.1% O-Phosphoric acid pH adjusted to 4 with TEA: Acetonitrile (45:55%v/v) Mode: Isocratic Detection wavelength: 239nm Flow Rate: 1.0 ml/min RT DGZ: 3.875 min RT LGN: 5.275 min |
52 |
|
Simultaneous Estimation of Dapagliflozin and Saxagliptin: Analytical Method Development and Validation |
International Journal for Pharmaceutical Research Scholars, 2024 |
RP-HPLC Column: Luna C18 (150 mm × 4.6 mm, 5 µm) M. P.: Phosphate Buffer pH 3.0: Acetonitrile (45:55 %v/v) Mode: Isocratic Detection wavelength: 228nm Flow Rate: 1.0 ml/min RT DGZ: 6.90 min RT Saxagliptin: 2.36 min |
53 |
|
RP – HPLC Method Development and Validation for Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Linagliptin |
International Journal of Pharmaceutical Sciences Review and Research, 2023 |
RP-HPLC Column: shim – pack solar C18 (250mm ? 4.6mm, 5 µm) M. P.: Acetonitrile: Phosphate buffer (pH -3 adjusted with 0.1 % OPA) (60:40 %v/v) Mode: Isocratic Detection wavelength: 225nm Flow Rate: 1.0 ml/min RT DGZ: 4.002 min RT Linagliptin: 2.344 min |
54 |
|
Method Development and Validation of Dapagliflozin by RP-HPLC |
Journal of Pharmaceutical Negative Results, 2022 |
RP-HPLC Column: Inspire (4.6 x 150mm, 5μm) M. P.: Methanol and Water (80:20 %v/v) Mode: Isocratic Detection wavelength: 235nm Flow Rate: 1.0 ml/min RT DGZ: 4.422 min |
55 |
|
A Review on Analytical Methods of Dapagliflozin: An Update |
International Journal of Pharmaceutical Quality Assurance, 2020 |
RP-HPLC Column: M. P.: Methanol : Acetonitrile : Orthophosphoric acid (70:25:5 %v/v) Mode: Isocratic Detection wavelength: 246nm Flow Rate: 1ml/min RT DGZ: 2.797 min |
56 |
|
Method Development and Validation of a Stability-Indicating Reversed-Phase Liquid Chromatographic Method for the Simultaneous Estimation of Metformin and Dapagliflozin in Presence of their Degradation Products |
International Journal of Pharmaceutical Sciences Review and Research, 2019 |
RP-HPLC Column: Hypersil C18, 250x4.6 mm M. P.: 50 mM potassium dihydrogen phosphate buffer (pH 3.0): methanol (40:60 %v/v) Mode: Isocratic Detecti.on wavelength: 255 nm Flow Rate: 1.0 ml/min RT DGZ: 5.74 min RT MTF: 3.78 min |
57 |
|
Development and validation of dapagliflozin by reversed-phase high-performance liquid chromatography method and it’s forced degradation studies |
Asian Journal of Pharmaceutical and Clinical Research, 2017 |
RP-HPLC (245 nm or 224 nm). Column: Hypersil BDS C18 (250 mm × 4.6 mm, 5 µ) Mobile Phase: Buffer: Acetonitrile (60:40) Flow Rate: 1 ml/min |
58 |
Reported methods for Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate in combination:
|
Title |
Name of Journal with year of Publication |
Summary |
Ref. No. |
|
Development and Validation of RP-HPLC Method For Simultaneous Estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate in Synthetic Mixture |
International Journal of Pharmaceutical Sciences, 2025 |
RP-HPLC Column: HYPERSIL ODS C18, 250 mm*4.6 mm M. P.: Acetonitrile: water (75:25 %v/v) Mode: Isocratic Detection wavelength: 272 nm Flow Rate: 1.0 ml/min RT DGZ: 15.11 min RT MTF: 6.11 min |
59 |
|
Accelerated Stability Indicating LC Method for Simultaneous Quantification of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate |
Journal of Planar Chromatography, 2025 |
Thin-Layer Chromatography (TLC) S.P.: Precoated silica gel G60 F254 aluminum sheet (10 × 10 cm, 0.2 mm layer thickness) M.P.: Methanol:Ethyl acetate:25% ammonia (0.5:6:0.3, %V/V) Detection wavelength: 223 nm RF value of DGZ: 0.24 RF Value of BSL: 0.46 |
60 |
CONCLUSION:
The estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate, whether as single agents or in combination, is a critical aspect of pharmaceutical analysis to ensure drug quality, efficacy, and patient safety. A variety of analytical techniques—ranging from simple spectrophotometric methods to advanced chromatographic and hyphenated approaches—have been successfully developed and validated for their quantification. Each method offers distinct advantages in terms of sensitivity, specificity, cost-effectiveness, and applicability to routine quality control. Among these, high-performance liquid chromatography (HPLC) remains the most widely employed technique due to its robustness and precision. However, newer technologies such as LC-MS and stability-indicating methods offer enhanced capabilities, especially for complex formulations and regulatory requirements. This review underscores the importance of selecting appropriate analytical strategies based on the intended application, formulation matrix, and regulatory standards. Continued research and method development in this area will further support the safe and effective use of these therapeutically important agents.
REFERENCES
Purvi Ramanuj, Payal Vaja, Review on Analytical Techniques for Estimation of Dapagliflozin Propanediol Monohydrate and Bisoprolol Fumarate, Separate and In Combinations, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 8, 426-441. https://doi.org/10.5281/zenodo.16744633
10.5281/zenodo.16744633
