Development of UV Spectroscopic Method of Dapagliflozin with Some Validation Parameter

Ganesh Tiwari , Viral Maheshwari , Rohan Shakywanshi, Rukhsar khan, Dr. Bhoomi Patel,

doi:10.5281/zenodo.15317978

Research Paper | Open Access
Volume 03 | Issue 05 | Article Id IJPS/250304624

Development of UV Spectroscopic Method of Dapagliflozin with Some Validation Parameter
Ganesh Tiwari * Viral Maheshwari Rohan Shakywanshi Rukhsar khan Dr. Bhoomi Patel
Department of Pharmaceutical Chemistry & QA, School of Pharmacy, Rai University, Saroda, Dholka, Ahmedabad, Gujarat - 382260, India

Abstract

This research compiles information on the development of analytical methods for estimating Dapagliflozin, which will be valuable for future research on this drug and its impurities. The literature survey covers various analytical methods such as UV, RP-HPLC, HPTLC, and other techniques reported for Dapagliflozin, both alone and in combination with other drugs. The analysis of published data indicates that only a UV spectroscopic method (calibration curve method) has been reported for estimating Dapagliflozin in fixed-dose combination. Each technique is evaluated for its sensitivity, specificity, and applicability in different matrices, including pharmaceutical formulations and biological fluids. The research also discusses the advantages, challenges, and recent advancements in these methods, providing a detailed comparison to guide researchers and practitioners in selecting the most appropriate technique for their specific needs.

Keywords

analytical methods, estimating Dapagliflozin, Development of UV Spectroscopic Method

Introduction

1.1 Introduction of Diabetes Mellitus

Diabetes mellitus is a metabolic disorder characterize by hyperglycemia where the patient experiences polyuria (frequent urination), polydipsia (extreme thirst), and polyphagia (constant hunger). Physicians have been documenting the signs and symptoms of diabetes for thousands of years.

The role of the pancreas in diabetes was discovered by the experiments of Oskar Minkowski who, in 1889, noted that when the pancreas was removed from a dog, the animal developed all signs and symptoms of diabetes. Small clusters of ductless cells on the pancreas were identified in 1869 by Paul Langerhans, and in 1902 the work of Eugene Opie clearly linked these ductless cells, which by then were called the islets of Langerhans, to diabetes. Although hypothetical secretion of the islet cells was postulated and called insulin (from insula, or island), it took work of Frederick Banting, Charles Best, and John Macloud to isolate insulin and use it as diabetes medication. insulin was identified as a protein by Frederick sangar and Hans Tuppy, who defined its amino acid sequence in 1951. The incidence of diabetes is growing rapidly worldwide. Approximately 30 million individuals in the United States and 422 million people globally are impacted by diabetes. In India, more than 62 million individuals are reported O1 be diabetic and it is predicted to reach 79.4 million U 2030. Diabetes is not a single disease, but rather a diverse group of syndromes characterized by high blood sugar levels, which can be caused by either a lack of insulin or a reduced ability to use insulin effectively. (02)

1.1.1 Classification of Diabetes

Table 1.1 classification of diabetes ⁽⁰³⁾

Types of diabetes

Type 1 Diabetes	•Effects children •Caused due to deficiency of insulin •Genetic variations & auto-immune response are leading cause
Type 2 Diabetes	•Effects adults •Caused due to insulin resistance by body •Obesity, inactive lifestyle, hereditary are leading cause
Gestational Diabetes	•Occurs during pregnancy •Excessive weight gain, genetic history of diabetes
MODY (maturity-onset diabetes of youth)	•Very rare •Caused in adults below 25 years of age •Caused due to genetic variation

1.1.3 Antidiabetic Drugs ⁽⁰¹⁾

These drugs lower blood glucose levels in diabetics and are effective orally. The chief drawback of injection. Orally insulin is-it must be given active drugs have always been caught.

Figure 1.1 flow-chart of oral Antidiabetic drug

1.2 Introduction of Dapagliflozin ⁽⁰²⁾

Dapagliflozin approved FDA in 2014. It binds well to plasma proteins (91%) and has an 80% bioavailability with a T_max of 1-2 hours. The plasma half-life of this substance is approximately 12. 9 hours, and it has a volume of distribution of 118 liters. Dapagliflozin is extensively metabolized, with 73.7% recovered in excrete (72.0% in urine and 1.65% in feces). Metabolic routes included glucuronidation (UGT1A9), DE alkylation, and oxidation at various positions to produce demethyldapaglifolzin glucuronides. The major metabolite is 3-O-glucuronide (60.7%) which is eliminated via the kidney. The 2-O-glucuronide was only other urinary metabolite. Similar to canagliflozin, dapagliflozin is also available in fixed combination tablets with metformin hydrochloride. In 2017, the FDA approved a fixed combination of dapagliflozin with saxaglitin.

This is a type of sodium glucose cotransporter 2(SGLT2).

Figure 1.2 Dapagliflozin structure.

1.2.1 Mechanism of action ⁽⁰³⁾

The sodium-glucose cotransporter 2 (Sglt2) is Answerable for Resorbing filtered glucose within the tubular lumen of the kidney. By blocking sglt2, these agents reduce the reabsorption of glucose, enhance the excretion of glucose in urine, and lower blood glucose levels. The inhibition of Sglt2 also leads to a decrease in sodium reabsorption and results in osmotic diuresis, which can potentially lower systolic blood pressure. However, they are not recommended for the treatment of high blood pressure. The monotherapy role of the SGLT2 inhibitors for patients who cannot tolerate met-forming SGLT2 inhibitors are also effective as an add-on to any of the other oral hypoglycemic and insulin. When administered once daily, they are well tolerated and do not have any relevant drug-drug interactions. They have a unique mechanism of action since they are insulin independent, which not only promotes reduction in plasma glucose but also contributes to weight loss, an improvement in blood pressure, and a low risk of hypoglycemia. This makes them good choice as an add-on medication for treating obese and/or hypertensive type 2 diabetics. Since the SGLT2 drugs are relatively new to the clinical arena, the data on long-term safety are lacking. Therefore, as their use increases, post market surveillance will increase our knowledge in this area.

1.3 Introduction to analytical method ^(6-7)

Development and validation of analytical procedures plays an important role in pharmaceutical product development, discovery, and manufacturing. Method development is a process of proving that an analytical method is acceptable for use to measure concentration of API in a specific compounded dosage form. The numbers of the drugs introduced into the market is increased every year. These drugs may be either new moiety or structural modification of the existing one, so there is possibility that analytical procedures for the new drugs may not be available in the pharmacopoeias. So, it is necessary to develop newer analytical methods for such drugs. Quality control laboratories use the official test methods to perform identity, purity, potency and performance tests for drug products. To Analyze the analyte there are several methods such UV Spectrophotometric, High Performance liquid chromatography, High performance thin layer chromatography, Ultra performance liquid chromatography, Stability indicating High Performance liquid chromatography, LC-MS/MS, spectrofluorimetric, GC/MS, etc. (7)

1.3.1 Introduction of UV Spectroscopy

Spectroscopy is the measurement and interpretation of the electromagnetic radiation absorbed or emitted when molecules or atoms or ions of a sample transitions from one energy state to another energy state. UV spectroscopy is a type of absorption spectroscopy in which light of the ultra-violet region (200-400 nm) is absorbed by the molecule which results in the excitation of the electrons from the ground state to a higher energy state.

Figure 1.2 Dapagliflozin structure.

Principle of UV Spectrophotometer

? When matter absorbs light, it ends up with a higher energy state, either at the atomic or molecular level.

? Ultraviolet radiations absorption leads to the excitation of the electrons from the ground state to a higher energy state.

? Molecules that possess π-electrons or nonbonding electrons (n-electrons) are able to absorb energy in the form of ultraviolet light to excite these electrons into higher anti-bonding molecular orbitals.

? Electrons that can be excited more easily can also absorb longer wavelengths of light. 3. There are four allowable transition types (π–π, n–π, σ–σ, and n–σ), which can be arranged in energy ordering of σ–σ* > n–σ* > π–π* > n–π* (6)

1.3.1.2 Instrumentation of UV Spectrophotometer

Figure 1.5 Instrumentation of UV Spectrophotometer

1.4 Drug Profile for DAPAGLIFLOZIN

Table 1.2 Drug profile of Dapagliflozin

Introduction

Name	Dapagliflozin
Official In	Dapagliflozin is official in Indian pharmacopeia (IP)
Description	It is a Na-glucose co-transporter to inhibit used in the management of Type-2 diabetes
Structure
Chemical formula	C₂₁ H₂₅CLO₆
Molecular weight	408.87
Category	Antidiabetic drug
Solubility	Soluble in organic solvent such as ethanol, DMSO & dimethyl formamide &sparingly soluble in Aqueous buffers.
CDSCO approved date	25-02-2015
IUPAC Name	(2S)-propane-1,2-diol(2S,3R,4R,5S,6R)-2{4-chloro-3-[(4-ethoxyphenyl) methyl] phenyl}-6-(hydroxymethyl) oxane-3,4,5-trio hydrate

PROPERTIES

State	Solid
CAS NO.	960404-48-2
Melting point	74-78^o C
Log P	2.11
Bioavailability	78 H (after long dose)
pKa	12.57

2. LITERATURE REVIEW

2.1 Reported method of DAPAGLIFLOZIN

Table 2.1 Literature review of DAPAGLIFLOZIN

Sr.No

Drugs

Official in

Analytical method

Description

Ref. No

Dapagliflozin

HPLC

ColumnC₁₈(15cm*4.6mm*5.4m)

Mobile phase =

potassium Dihydrogen orthophosphate: Acetonitrile (60:40)

Flow Rate = 1.4ml/min

Wavelength = 225 nm

(9)

Table 2.2 Literature review of DAPAGLIFLOZIN

Sr.No	Drugs	Analytical method	Description	Ref. No.
1	Dapagliflozin	UV spectroscopy 1. zero order 2. first order 3. second order	Solvent = Methanol Wavelength = Zero order = 224 nm 1^st order = 220 nm 2^nd order = 235.5 nm	(10)
2	Dapagliflozin	UV-spectroscopy	Solvent – Methanol Wavelength =225 nm	(11)
3	Dapagliflozin metformin HCl	UV-spectroscopy	Solvent – Methanol (1) Wavelength =235 nm (2) Wavelength =272 nm	(12)
4	Dapagliflozin saxagliptin	UV-spectroscopy	Solvent – phosphate buffer (6.8) v/v Wavelength _d =222 nm Wavelength s= 276 nm	(13)
5	Dapagliflozin Saxagliptin metformin HCL	UV-spectroscopy	Solvent = water Wavelength =223 nm Wavelength = 212 nm Wavelength = 232.6 nm	(14)
6	Dapagliflozin	RP-HPLC	Mobile phase-Acetonitrile: water (65:35) v/v Wavelength = 225 nm ColumnC₁₈(4.6100mm) Flow Rate =* 1ml/min	(15)
7	Dapagliflozin metformin	RP-HPLC	Mobile phase: -Phosphate Buffer: Acetone Nitrile (45:55) v/v Flow Rate =1ml/min	(16)
8	Dapagliflozin linagliptin	HPTLC	Solvent: - Chloroform;methanol;Trie-thylamine (7:2:1:0.2) v/v D(R_p) = 0.23 L(Rf) = 0.40	(17)
9	Dapagliflozin metformin	UV-spectroscopy	Solvent = methanol Wavelength = 275 nm Wavelength = 245 nm	(18)
10	Dapagliflozin sitaglipstin	UV-Visible	Solvent = methanol Wavelength =224 nm Wavelength = 263 nm	(19)
11	Dapagliflozin vildagliptin	RP-HPLC	Solvent= Methanol:Water (95:05) v/v Wavelength = 210 nm Flow Rate = 0.8 ml/min	(20)
12	Dapagliflozin	RP-HPLC	Solvent =Acetone Nitrile:Water (52:48) v/v Flow Rate = 1ml/min UV Detector: - 224 nm	(21)
13	Dapagliflozin	RP-HPLC	Solvent = Methanol: Phosphate buffer (45:58) v/v Wavelength = 255 nm Flow rate = 1 ml/Min	(22)
14	Dapagliflozin Teneligliptin	UV-spectroscopy = Simultaneous equation Q-absorbance Ratio First derivative (Zero crossing)	Solvent-Distilled water (1) Wavelength _D=223 nm Wavelength_T=243 nm (2)Wavelength_D =223 nm Wavelength_T =230 nm (3)Wavelength_D=237 nm Wavelength_T=254 nm	(23)
15	Dapagliflozin Saxagliptin metformin	UV-spectroscopy= Visible	Solvent-Methanol: Water (80:20) v/v (1) Wavelength _d =272 nm (2) Wavelength_s =212 nm (3) Wavelength _m=232 nm	(24)
16	Dapagliflozin Vildagliptin	UV-spectroscopy= Simultaneous Equation Method Absorbance Ratio Method Second Derivative Zero Crossing Method Ratio Difference Spectroscopic method First Derivative of Ratio spectra Method	(1)Wavelength_D =223 nm Wavelength_V =210 nm (2)Wavelength_D =223 nm Wavelength_V =219.2 nm (3)Wavelength_D=290.6 nm Wavelength_V =219.2 nm (4)Wavelength_D =236&242 nm Wavelength_V=208.4&215 nm (5)Wavelength_D =226 nm Wavelength_V =215.6 nm	(25)

3. RESULT & DISCUSSION

3.1 SOLUBILITY OF DAPAGLIFLOZIN⁽²⁶⁾

Table 3.1 Solubility of Dapagliflozin

Sr..No	Solvent	Solubility
1	Water	Slightly Soluble
2	Ethanol	Soluble
3	Organic solvent (DMSO)	Freely Soluble
4	HCl	soluble

3.2 INTERPRETATION OF IR SPECTRA⁽²⁷⁾

Table 3.2 Interpretation of IR Spectra

FIGURE	STD. Frequency	Sample Frequency
C=C (aromatic)	1600 – 1475 cm^-1	1600 cm^-1
C-O	1300 – 1000 cm^-1	1050 cm^-1
O-H	3400 – 3200 cm^-1	3300 cm^-1
C-H	3000 – 2850 cm^-1	2900 cm^-1
C-O-H	1300 – 1000 cm^-1	1250 cm^-1
C-Cl	785 – 540 cm^-1	750 cm^-1

Figure 3.1 IR Spectra of dapagliflozin

Figure 3.2 Chemical Structure of Dapagliflozin

3.3 MELTING POINT⁽²⁸⁾

Table 3.3 Melting Point

DRUG	STD.	SAMPLE
Dapagliflozin	74-78^°c	76-78°c

3.4 UV SPECTROSCOPY METHOD

A standard UV solution was analyzed within the range of 200 to 400 nm, showing an absorption peak at 222 nm. The absorption spectrum for Dapagliflozin is presented in Figure 3.3.

3.4.1 preparation of sample solution

Twenty tablets were carefully weighed and ground using a mortar and pestle. An amount corresponding to 20 mg of Dapagliflozin was measured and dissolved in a 100 ml volumetric flask containing 0.1N HCl. The solution was subjected to sonication for a duration of 15 minutes, resulting in a concentration of 200 µg/mL

Figure 3.3 UV Chromatogram of Dapagliflozin

3.5 METHOD OF VALIDATION FOR UV ⁽⁸⁾

LINEARITY: - Calibration curve for Dapagliflozin is plotted using the UV technique, throughout range of 5–30 µg/ml. The solution was scanned at 222nm in UV. The records obtained were then subjected to regression analysis using the least squares method, to determine the relationship between variables. Significant linear connections between response and concentration were shown by the linear regression results. Linear regression coefficient for UV (R² = 0.9982) is determined

Table 3.4 Linearity of Dapagliflozin

SR.NO	Concⁿ (µg/ml)	Absorbance 1	Absorbance 2	Absorbance 3	SD
1	5	0.02	0.024	0.022	0.002
2	10	0.058	0.054	0.056	0.002
3	15	0.1	0.099	0.097	0.001528
4	20	0.146	0.143	0.149	0.003
5	25	0.187	0.185	0.189	0.002
6	30	0.22	0.23	0.2	0.015275
				Avg	0.0043

Figure 3.4 Calibration curve

Precision:

Precision in an analytical procedure refers to how consistently similar results are obtained when the same sample is measured multiple times under the same conditions. It reflects the reproducibility of measurements taken from repeated sampling of the same material using a specific method.

- Intraday:-

Table 3.5 Intraday study results

Concentration: (µg/ml)	Absorbance	Standard Deviation
5	0.025	0.00057
	0.024
	0.025
Mean	0.024666667

15	0.101	0.00100
	0.1
	0.099
Mean	0.1

25	0.185	0.00044
	0.186
	0.185
Mean	0.185333333

Interday:-

Table 3.6 Interday study results

Concentration: (µg/ml)	Absorbance	Standard Deviation
5	0.025	0.00057
	0.024
	0.025
Mean	0.024666667

15	0.101	0.00100
	0.1
	0.099
Mean	0.1

25	0.185	0.00044
	0.186
	0.185
Mean	0.185333333

- Repeatability:-

Table 3.7 Repeatability study results

Concentration : (µg/ml)	Absorbance	Standard Deviation
15	0.102	0.001048809
	0.099
	0.1
	0.101
	0.1
	0.101
Mean	0.1005

Range:- The linearity range for UV method development for Dapagliflozin shown in Table.

Table 3.8 Linearity Range of Dapagliflozin

Parameters	DAPAGLIFLOZIN by UV (Sample) (µg/ml)
Linearity Range (µg/ml)	5 – 30

Limit of Detection & Limit of Quantification - The limits of detection (LOD) and quantification (LOQ) were determined using the 3.3 σ/s and 10 σ criteria, respectively, with σ being the standard deviation of the peak area and S, the slope of the resulting calibration curve. The UV LOD and LOQ were established. Results of LOD and LOQ are shown in Table.

Table 3.9 LOD & LOQ of Dapagliflozin

Parameters	sample
LOD	1.7304µg/ml
LOQ	5.2439µg/ml

LOD = 3.3σS

[where σ=standard deviation and s=slope]

LOD = 3.3*0.0043/0.0082=1.7304µg/ml

LOQ = 10σS

LOQ = 10* 0.0043/0.0082=5.2439µg/ml

3.6 Summary of validation parameter

Sr. no	Parameter	Dapagliflozin
1	Linearity (µg/ml)	0.0043 (µg/ml)
2	Regression equation ( y = mx + c)	y = 0.0082x - 0.0215
3	Slop (m)	0.0082x
4	Intercept (c)	0.0215
5	Correlation coefficient (r)	0.9982
6	Precision 1. Repeatability 2.Intraday 3.Interday	0.001048809 0.00044-0.00100 0.00044-0.00100
7	Range (µg/ml)	5-30 (µg/ml)
8	LOD(µg/ml)	1.7304µg/ml
9	LOQ(µg/ml)	5.2439µg/ml

CONCLUSION

In conclusion, the method proved effective for estimating the amount of Dapagliflozin in tablet dosage forms containing 10mg. The validation parameters demonstrated that the method is linear, precise and repeatable, ensuring reliable results. Furthermore, the method's simplicity in calculation and ease of execution make it ideal for routine analysis of marketed formulations. It is also suitable for use in dissolution testing, offering an efficient and practical approach for quality control in pharmaceutical settings. This method could be readily adopted for consistent and accurate monitoring of Dapagliflozin in various dosage forms.

REFERENCES

KD Tripathi, essentials of medical Pharmacology,8th Edition,Japee Brothers Medical Publishes PVT. Ltd, New Delhi, 2019, p.g. 293,258
Victoria F.roche,S.William Ziot, Thomas L.lemke,David A. William, South-Asian Edition of Foye's Principle of Medicinal Chemistry. Wolter Kluwer, pg.792-793,794,817
Sangeeta Sharma, Thirumoorthy velpandian , Lippincott Illustrated Reviews, PHARMACOLOGY, South Asian edition, Wolters Kluwer, pp no.437, 449-450
Drug Profile of dapagliflozin, Dapagliflozin: Uses, Interactions, Mechanism of Action | DrugBank Onlin
Drug Profile of dapagliflozin, Dapagliflozin: Uses, Dosage, Side Effects, Warnings - Drugs.com
Vidyasagar G, “instrumental Method of Drug Analysis” Pharma Med press, Hyderabad,2010, pg. 106-147,156-17
Chawal Gr, Anand SK, “Instrumental Method of Chemical Analysis”. Himalaya Publishing House PVT.LTD,2018, pg.- 2149-2184,2624-2639.
International Conference on Harmonization (ICH) of technical Requirements for the Registration of Pharmaceuticals for Human use, Validation of Analysis Procedure: Text & methodology, Q2 (R1), Geneva 2005.
Draft proposal for comments and inclusion in the Indian pharmacopoeia,2023 https://www.ipc.gov.in/images/Dapagliflozin_Propanediol_Monohydrate.pdf
Gajanan Vithoba Manthe, Krishna Radheshyam Gupta & Atul Trymbatrao Hemik, “Estimation of Dapagliflozin From its Tablet Formulation by UV- Spectroscopy”. Pharm Methods,2017; 8(2); 102-107.
Jani BR, Shah KV Kapupara pp “Development and validation of UV Spectroscopy method for simultaneous Estimation of Dapagliflozin”. International Journal of Research & Development in Pharmacy and Life Science, April- May,2015, VOL 4(3) pg. 1569-1576.
Jani BR, Shah KV Kapupara pp Development and Validation of UV Spectroscopy First Derivative Method of Simultaneous Estimation of Dapagliflozin & metamorphic HCL in Synthetic Mixture. General of Bioequivalence Studies 1(1) Pg.102
Raghvendra Singh Bhaduria, Uikas Agarwal, “Development and Validation of UV Spectroscopy method for simultaneous estimation of dapagliflozin & Saxagliptin in marked formulation” Journal of drug delivery and therapeutics, 2019, 9 (4-s): Pg. 1160-1164
Dhanya B Sen, Sohil Jatu, Rajesh A Maheshwari, Arti Sachin Zanwar, Rama Swamy Velmurugan, Ashim Kumar sen, “New Eco-Friendly UV Spectroscopy Methods of Simultaneous Assessment of Dapagliflozin, Saxagliptin, Metamorphin in Tartary, Mixture. Ind. J. Pharma. Edu. Release 2023; 57(2), pg. 559-569
Shraddha Mahabali, Ganesh Gajeti, Mallinath Kalshetti, RP-HPLC & UV Spectroscopy Method Development and validation for Estimation of Dapagliflozin in bulk and pharmaceutical dosage Form. “Journal of Cluster Science, 1, 12 June 2024.
Waker Siddiqui, Zulcaif Hussain Ummar, Sufyan Junaid Unmai Muhmmad Waqas, Maria Gul Mubashra Gul, “Method Development and Validation of metamorphin HCL & Dapagliflozin by using RP-HPLC". AK journal 10 July 2024.
Anchal Shukla, Usman Gani Chhalotiya, Dimal Shah, Jinal Tandal, Heta Kachhiya, Mital Parmar, “development and validation of stability Indicating HPLC method for simultaneous estimation of Dapagliflozin & Linagliptin”. Discover Chemistry (2024) 1(4)
Deepak Dalal, Ravi klant Kavita Aftari, Kiran Sharma, Meena Kashi Danavat, “spectrophotometric Absorption Correction Methods for the Estimation of Fixed-dose Combination of Dapagliflozin & Metamorphin HCL, Indian Journal pharma Edu. Res, (2024) 58 (1), Pg. 291-296
Mayank Yadav, Rekha Chautin, Ranjit Singh, Neha Tiwari. “UV-spectroscopy approaches for concurrent assessment of Sipaglitpin & Dapagliflozin”, African Journal of biological science ,2024; Vol 6 (9); Pg. 2187-2663.
Bhavesh H. Patel, Nishit H. Perdiya, “simultaneous estimation and stability indication method of Vildagliptin & dapagliflozin by RP-HPLC in pharmaceutical dosage form”, Journal Publication 2024 (1).
Chaudary Ujwal, Sahu Jagdish K, Dande Payal K, analytical method development validation and force degradation study of Dapagliflozin by RP-HPLC, “drug metabolism and bioanalysis letters formally; drug metabolism letters,2023;16(2), Pg 240-652.
S. Sravanthi, Neha Zarin, B. shruti D. Ramya Krishna, A. manjeera , “new analytical method development and validation for the estimation of Dapagliflozin by using reverse phase HPLC, International Journal of Advanced Research in Medical and pharmaceutical science, 4 July 2021, volume 6
Anokhi Patel, Preeti Jadeja and Dr. Rajashree Mashru. “Analytical method Development and validation for situations estimation of Dapagliflozin and Tene gliptin Hydro bromide hydrate synthetic mixture by three different UV-spectrophotometry methods”. World journal of pharmaceutical Research, VOL 11(7), Pg. 770-785.
Barbuda Priya, Jawar Mukkund, Burange Prashant, “method development using UV-visible spectrometer of the simulations estimation of Metamorphin (MET), sexagliptin (SXG) and Dapagliflozin (DGF) in Marketed formulation”. Asian journal of pharmaceutical analysis (2022), VOL 12(4), Pg 234-247.
Asami Kumar sen, Satish B. Kataria Dhaniya B Sen, Ramesh A Maheshwari, Arti S. Zanwar, Ramaswamy Velmurugan, “various Innovative UV spectroscopic methodologies for Concurrent estimation of Dapagliflozin and Vildagliptin in combined tablet” Journal of applied pharmaceutical science VOL.13(09), Pg 213 -223, sep(2023).
Government of India, Indian Pharmacopoeia, Ninth Edition(9.0), Volume 1, Page Number- 264, The indian pharmacopoeia commission Ghaziabad– 2022.
Donald l. pavia, Gary m. lampman, George s. kriz, Jamrs r. Vyvyan, Introduction of Spectroscopy , Fifth edition, Brooks/Cole Publisher, 2014, page no-
Shilpi Pathak. Development and Validation of UV-Spectroscopy Method for the Determination of Dapagliflozin. Bull.Env. Pharmacol. Life Sci., Vol 9[12] November 2020 :128-133.