Comparative Quality Assessment of Branded and Generic Metformin Prolonged-Release Tablets and Glimepiride Tablets using Assay, In-vitro Dissolution Testing and Statistical Approaches (Model-Dependent and Model-Independent Approaches)

 

Deepak Mandal1,2, Manisha Trivedi2, Meenakshi Dahiya2, Robin Kumar2, Dharam Pal Pathak1, Nupur Tomar2, Rajan Choudhary2

1,2Quality Assurance, Deepak Mandal, Delhi Pharmaceutical Science and Research University, New Delhi, India.

2Reference Standard Division, Dr. Manisha Trivedi, Indian Pharmacopoeia Commission, Ghaziabad, India.

2Quality Assurance Head, Dr. Meenakshi Dahiya, Indian Pharmacopoeia Commission, Ghaziabad, India.

2Reference Standard Division, Dr. Robin Kumar, Indian Pharmacopoeia Commission, Ghaziabad, India.

1Pharmaceutical Chemistry, Dr. Dharam pal Pathak, Delhi Pharmaceutical Science and Research University, New Delhi, India.

2Reference Standard Division, Dr. Nupur Tomar, Indian Pharmacopoeia Commission, Ghaziabad, India.

2Reference Standard Division, Mr. Rajan Choudhary, Indian Pharmacopoeia Commission, Ghaziabad, India.

*Corresponding Author E-mail: rudrasanty2001@gmail.com, ipcmanisha@gmail.com, meenakshi.ipc@gov.in, robinkumar21@gmail.com, drdppathak@gmail.com, nupurtomar85@gmail.com, rajanchoudhary413@gmail.com

 

ABSTRACT:

Background: This study explores the pharmacological features of metformin hydrochloride and glimepiride, two widely recommended medicines for controlling type 2 diabetes mellitus. Objective: The primary objectives were to assess the dissolving profiles, confirm the uniformity of the active pharmaceutical components, and evaluate conformity to pharmacopoeial standards in branded and generic formulations. Methods: We employed UV spectroscopy and high-performance liquid chromatography (HPLC) to conduct extensive evaluations. The absorption profile of UV spectroscopy revealed the measurement of the concentration of the medication in different formulations. HPLC had provided precise separation and quantitation and proved the purity and concentration of various samples. The dissolving studies were performed to detect the differences in the release of branded and generic preparations. Univariate ANOVA, and t-tests were applied to determine consistency and reproducibility of data through statistical analysis. The use of Graphical representation and interpretation, non mathematical models (f1, f2, and the Rescigno ratio), mathematical models (zero order, first order, Higuchi, Pappas, Sahlin, Hixson-Crowell, Baker-Lader, Kos Meyer-Pappas) used to describe the dissolution profiles. Results: The dissolution studies showed there were major variations between the brand and generic formulations concerning the rate of release which could affect the bioavailability and efficacy of a drug. Consistency and trustworthiness were supported with the help of statistical study. In conclusion, our results emphasize the high importance of standard analytical measures in the process of ensuring drug quality and drug efficacy. The given work contributes insightful experience to the pharmaceutical analysis of the anti-diabetic medications, which benefit establishing the reliable formulations of generics and highlighting the importance of quality control in the pharmaceutical industry.

 

KEYWORDS: Metformin hydrochloride, glimepiride, UV spectroscopy, high-performance liquid chromatography, Pharmacopoeial standards, bioavailability, therapeutic efficacy, quality control, generic formulations.

 

 


1. INTRODUCTION: 

The assurance of the efficacy and safety of pharmaceuticals is essential in the sphere of pharmaceutical sciences1. The given research takes a new step to inquire into the quality of metformin prolonged-release formulations and their generic substitutes through extended assay and in-vitro dissolution testing.2 In the study, the researchers explain the importance of such tests as essential quality control methods that are used to ensure that both branded and generic copies of drugs have high pharmaceutical standards.3,4 Diabetes mellitus (DM) is a prolonged condition of high sugar blood levels, which requires effective pharmaceutical remedies to control.5 Glimepiride and metformin hydrochloride are two of the key medicines used in treating type two diabetic mellitus (T2DM).6 Metformin is a biguanide that enhances insulin sensitivity and reduces glucose production in the liver, glimepiride, a member of a sulfonylurea, increases insulin secretion by the pancreatic beta cells.7 Since these pharmaceuticals are used widely, it is crucial to ensure that their extent of performance in branded and generic form is assured in terms of quality, efficacy and safety.8,9 This work utilises high performance liquid chromatography (HPLC) and ultraviolet-visible (UV-Vis) spectroscopy to analyse the assay of metformin and glimepiride formulations.10,11,12 This HPLC is a strong analysis tool that allows an accurate quantification of a product and also guarantees the detection of contaminants that may be present in the given product.13,14,15,16 This makes this technique more valid assessing the purity and the potency in the given drug.17,18 The overall research utilizes current spectroscopic tools like the in the analytical process that was used here is quite proficient as it not only strengthens this study in terms of its findings due to its reliability but also marks the beginning of future computations involving quality assurance of drugs.19 Through the advanced form of statistical testing, such as the use of univariate ANOVA and the t-tests, the study confirms the reliability and recyclability of its conclusions, which ensures that the findings are scientifically sound and clinically applicable.20,21,22

 

1.1. Graphical Representation Of Dissolution Profile Data:  Metformin Samples:

 

Fig. 1. % Release vs. Time

Initial time point (0.25hours):

Ref.1 and Ref.2 showed close values (17.78, 18.98). Test samples varied, highest in Test.1 (21.51) and lowest in Test.6 (15.17).

 

Early time point (1hour):

Ref.1 and Ref.2 remained similar (36.13, 35.67). Test.2 and Test.3 were close to reference (36.51, 36.45), while Test.5 and Test.6 showed lower values (31.07, 32.75).

 

Mid time point (3 hours):

Ref.1 and Ref.2 were similar (48.32, 47.81). Test.1 matched Ref.1 (48.22), while Test.2 - 5 showed higher values (59.79 - 58.89). Test.6 was slightly lower (55.15)

 

Later time point (5 hours):

Ref.1 and Ref.2 were close (66.63, 69.19). All tests showed higher values, with Test.4 highest (73.67) and others slightly above references (68.64 -72.95).

 

Final time point (8 hours):

Ref.1 and Ref.2 were similar (93.52, 92.96). Test samples aligned closely, except T3 (88.63). Reference profiles were uniform; tests varied at 3 h but matched by 8 h.

 

1.2. Symbols:

Symbols:

1.     K0, K1, KH, KKP, KHC, KBL, K1, K2 - Rate constants for various drug release models (Zero-order, First-order, Higuchi, Korsmeyer-Peppas, Hixson-Crowell, Baker-Lonsdale, Peppas-Sahlin).

2.     RSQR_ADJ - Adjusted R-square, MSE_ROOT - Root Mean Square Error

3.     AIC - Akaike Information Criterion, MSC - Model Selection Criterion.

4.     n - Exponent, f1 - Difference factor ,f2 - Similarity factor

5.     ζ1, ζ2 - Rescigno indices

 

Table1. List of instruments

Instrument

Brand/Model

Manufacturer

HPLC System

Agilent 1200

Agilent Technologies

Uv-Visible Spectrophotometer

Lambda 35

Perkin Elmer

Dissolution Apparatus

Ds 8000

Lab India

Sonicator

Branson Sonicator

Mettler Toledo

Water Purification System

Integral 3 Q-Pod

Millipore Co. Bedford USA

Ph Meter

Seven Compact Ph/Ion S220

Mettler Toledo

Syringe Filter

RanDisk

Rankem

Digital Weighing Balance

-

Mettler Toledo

Analytical Column

Inertsil (C18 150*4.6mm 5µm)

-

Membrane Filters

Millipore

Axiva

Hot Air Oven

-

-

Glassware

-

Borosil

 


Table2. List of the Chemicals and Reagents

Chemicals

Manufacturer/Supplier

Metformin (Working Standard)

Torrent pharmaceuticals

Glimepiride (IPRS)

Indian pharmacopoeia commission Ghaziabad

Potassium dihydrogen phosphate

Finar

Sodium hydroxide

Sigma-Aldrich

Sodium dihydrogen phosphate

Finar

Methanol (HPLC grade)

Rankem

Acetonitrile (HPLC grade)

Finar

Distilled water

Millipore

 

Table 3. Metformin Hydrochloride Prolonged-Release 500 mg Tablets

Sample Type

Sample

Assay Results (%)

Time (Hr.)

Dissolution Profile (%)

Branded

R1 (EXERMET 500 SR)

100.25

0.25

17.78

1

35.49

3

48.32

5

66.63

8

93.52

Branded

R2 (GLUCOFORMIN XL 500)

99.85

0.25

18.98

1

35.67

3

47.81

5

69.19

8

92.96

Generic

T1 (METFORNIL SR 500)

100.27

0.25

21.50

1

34.60

3

48.22

5

68.64

8

94.55

Generic

T2 (METFORM SR 500)

101.36

0.25

15.17

1

32.75

3

55.15

5

72.18

8

93.15

Generic

T3 (DAILYGLIM 500 SR)

101.08

0.25

15.39

1

31.07

3

58.89

5

72.95

8

90.75

Generic

T4 (METROSE 500 SR)

99.88

0.25

15.49

1

36.51

3

59.79

5

69.81

8

90.15

Generic

T5 (ELCEPHASE 500 SR)

101.48

0.25

16.61

1

36.14

3

58.66

5

73.67

8

92.29

Generic

T6 (METFORMIN HCL (J.A))

100.92

0.25

18.38

1

36.45

3

60.90

5

69.94

8

88.63

All samples met pharmacopoeial standards (API 90 -110%). Both branded and generic forms released >85% within 8 hours, confirming consistent efficacy.

 


Table 4. Glimepiride 1 mg Tablets

Sample Type

Samples

Assay

(%)

Dissolution Profile at 30 mins (%)

Branded

R3 (Glimda-1)

92.79

96

 

R4 (Glimestar-1)

102.67

99

Generic

T7 Glimepiride HCl (Jan Aushadhi)

99.38

91

 

T8 (Glidum-1)

96.29

89

 

T9 (Glyzee-1)

101.08

94

 

T10 (Glyfic-1)

99.88

83

 

All samples met IP 2022 standards (API 90 -110%). Both branded and generic forms released >75% in 30 minutes, confirming consistent efficacy.

 

Non-Mathematical Models (Model-Independent Approach):

 

Table 5. f1, f2, and Rescigno Index (ζ1, ζ2) for Test Products

Test Product

f1

(Ref.1)

f1

(Ref.2)

f2

(Ref.1)

f2

(Ref.2)

ζ1

(Ref.1)

ζ1

(Ref.2)

ζ2

(Ref.1)

ζ2

(Ref.2)

Test.1

3.20

2.32

81.98

87.72

0.0115

0.0078

0.0132

0.0087

Test.2

7.89

7.46

62.14

61.73

0.0396

0.0342

0.0490

0.0487

Test.3

8.00

7.12

61.02

61.18

0.0422

0.0362

0.0520

0.0511

Test.4

7.54

7.12

62.08

63.14

0.0424

0.0371

0.0509

0.0467

Test.5

10.33

9.54

60.19

61.04

0.0519

0.0451

0.0537

0.0498

Test.6

7.14

6.52

67.39

68.51

0.0360

0.0299

0.0384

0.0339

Overall Statistics

Mean

SE

Mean

SE

Mean

SE

Mean

SE

Mean_R Vs Individual

6.92

0.99

66.78

3.94

0.0341

0.0056

0.0408

0.0067

Mean_R Vs Mean_T

6.18

 

67.64

 

0.0323

 

0.0381

 

 


The mean f1 (6.18) and f2 (67.64) values fall within acceptable limits, confirming similarity between test and reference profiles. Low Rescigno Index (ζ₁) and minimal errors further support their close equivalence in dissolution behaviour.

 


 

UNIVARIATE ANOVA OUTPUT

Table 6. Anova Results

Source of Variation

Sum of Squares (SS)

Degrees of Freedom (DF)

Mean Square (MS)

F-Value

p-Value

F Critical (F Crit)

Between Groups

50,836.47

1

50,836.47

141.68

3.23E-19

3.96

Within Groups

27,987.87

78

358.82

 

 

 

Total

78,824.33

79

 

 

 

 

The F-value (141.68 > 3.96) and low P-value (<0.05) indicate significant differences in release over time, confirming a sustained-release profile.

 

T-Test Results

Table 7. p-Values for Pair-wise Comparisons

Comparison

P-Value

Ref.1 vs. Test.1

0.956574307

Ref.1 vs. Test.2

0.921271729

Ref.1 vs. Test.3

0.903645267

Ref.1 vs. Test.4

0.876254211

Ref.1 vs. Test.5

0.945382522

Ref.1 vs. Test.6

0.95094842

Ref.2 vs. Test.1

0.975350028

Ref.2 vs. Test.2

0.939827323

Ref.2 vs. Test.3

0.922554102

Ref.2 vs. Test.4

0.894298915

Ref.2 vs. Test.5

0.963547946

Ref.2 vs. Test.6

0.969040683

All p-values >0.05, indicating no significant difference and confirming similarity between test and reference dissolution profiles.

 

MATHEMATICAL MODELS:

(Model-dependent Approach):Table 8. Interpretation Of Data for Different Models

Time (hour)

Ref.1

Ref.2

Test.1

Test.2

Test.3

Test.4

Test.5

Test.6

0.25

17.78

18.98

21.51

15.49

18.38

16.61

15.39

15.17

1

36.13

35.67

34.6

36.51

36.45

36.14

31.07

32.75

3

48.32

47.81

48.22

59.79

60.19

58.66

58.89

55.15

5

66.63

69.19

68.64

69.81

69.94

73.67

72.95

72.18

8

93.52

92.96

94.55

90.15

88.63

92.29

90.75

93.15

 

Table 9. Parameters of the mathematical models and descriptive statistics for the dissolution data

Model

Metric

NO.1

NO.2

NO.3

NO.4

NO.5

NO.6

NO.7

NO.8

Zero Order

K0

10.203

10.112

9.795

10.150

10.039

10.188

10.198

10.177

RSQR_ADJ

0.5563

0.4377

0.2569

0.3848

0.4717

0.5418

0.6133

0.5808

MSE_ROOT

21.2688

23.5171

25.0017

24.5673

23.3288

22.2707

20.3130

20.861

AIC

48.3435

49.5494

50.2840

50.0736

49.4529

48.8959

47.7918

48.1113

MSC

0.4792

0.2424

-0.0364

0.1525

0.3047

0.4472

0.6167

0.5362

First Order

K1

0.275

0.303

0.298

0.314

0.297

0.293

0.270

0.273

RSQR_ADJ

0.9068

0.9506

0.9210

0.9575

0.9764

0.9703

0.9177

0.9195

MSE_ROOT

9.7483

6.9724

8.1497

6.4551

4.9317

5.6693

9.3688

9.1398

AIC

38.9818

34.9602

36.8325

34.0350

30.8047

32.4775

38.5052

38.2083

MSC

2.0395

2.6740

2.2056

2.8256

3.4128

3.1836

2.1644

2.1867

Higuchi

KH

30.596

30.634

29.903

30.840

30.393

30.699

30.498

30.498

RSQR_ADJ

0.9643

0.9652

0.9306

0.9517

0.9617

0.9739

0.9746

0.9724

MSE_ROOT

6.0301

5.8498

7.6427

6.8831

6.2776

5.3196

5.2010

5.3565

AIC

33.2179

32.8535

36.0616

34.8055

33.7004

31.7134

31.4427

31.7964

MSC

3.0002

3.0251

2.3340

2.6972

2.9302

3.3109

3.3415

3.2553

Korsmeyer-Peppas

KKP

33.780

36.080

37.661

36.985

34.929

34.091

32.578

33.250

n

0.449

0.416

0.381

0.407

0.429

0.446

0.466

0.456

RSQR_ADJ

0.9633

0.9827

0.9752

0.9734

0.9700

0.9767

0.9716

0.9714

MSE_ROOT

6.1142

4.1253

4.5684

5.1039

5.5567

5.0270

5.5042

5.4524

AIC

34.0452

29.3234

30.5477

31.8777

32.8978

31.6957

32.7838

32.6704

MSC

2.8623

3.6134

3.2530

3.1851

3.0639

3.3139

3.1180

3.1097

Hixson-Crowell

KHC

0.073

0.080

0.080

0.084

0.080

0.078

0.071

0.072

RSQR_ADJ

0.8986

0.9145

0.8661

0.9258

0.9504

0.9541

0.9102

0.9099

MSE_ROOT

10.1652

9.1700

10.6123

8.5300

7.1510

7.0465

9.7867

9.6695

AIC

39.4843

38.2479

40.0008

37.3797

35.2637

35.0869

39.0289

38.8844

MSC

1.9558

2.1260

1.6775

2.2681

2.6696

2.7487

2.0771

2.0740

Baker-Lonsdale

KBL

0.028

0.029

0.028

0.030

0.028

0.029

0.027

0.027

RSQR_ADJ

0.9457

0.9880

0.9927

0.9881

0.9821

0.9746

0.9472

0.9521

MSE_ROOT

7.4384

3.4360

2.4705

3.4227

4.2948

5.2413

7.5070

7.0511

AIC

35.7365

26.4682

22.5097

26.4219

29.1455

31.5354

35.8466

35.0949

MSC

2.5804

4.0893

4.5927

4.0944

3.6893

3.3406

2.6075

2.7056

Peppas-Sahlin

K1

19.688

38.230

40.504

38.607

35.138

34.434

16.099

13.475

K2

14.281

-3.458

-4.302

-3.800

-3.219

-2.920

16.660

19.899

M

0.297

0.562

0.553

0.603

0.660

0.644

0.292

0.273

RSQR_ADJ

0.9532

0.9908

0.9901

0.9918

0.9959

0.9893

0.9631

0.9625

MSE_ROOT

6.9102

3.0013

2.8887

2.8354

2.0623

3.4060

6.2773

6.2390

AIC

35.7876

25.7803

25.3213

25.0979

21.2777

27.2981

34.6349

34.5615

MSC

2.5719

4.2039

4.1241

4.3151

5.0006

4.0468

2.8095

2.7945

K0: Zero-order rate constant; K1: First-order rate constant; KH: Higuchi constant; KKP: Korsmeyer-Peppas constant;

n: Release exponent; KHC: Hixson-Crowell constant; KBL: Baker-Lonsdale constant; K1 and K2: Release exponents;

RSQR_ADJ: Adjusted R2; MSE_ROOT: Root mean square error; AIC: Akaike Information Criterion; MSC: Model selection criterion.

 


2. MATERIALS AND METHOD:

2.1. Materials:

Metformin Hydrochloride Prolonged-Release 500 mg Tablets:

 

Reference (Branded):

Metformin Hydrochloride Prolonged-Release 500 mg Tablets (Reference No. R1, R2)

 

Test (Generic):

Metformin Hydrochloride Prolonged-Release 500 mg Tablets (Test No. T1, T2, T3, T4, T5, T6)

 

Glimepiride 1 mg Tablets:

Reference (Branded):

Glimepiride 1 mg Tablets (Reference No. R3, R4)

 

Test (Generic):

Glimepiride 1 mg Tablets (Test No. T7, T8, T9, T10)

 

2.2. Methods:

Metformin Hydrochloride (UV Spectrophotometry)

Diluent: Water

 

The assay of Metformin Hydrochloride, A 20 mg working standard was dissolved in water, diluted, and filtered (0.45 µm PVDF). For the sample, 20 tablets were powdered, and an equivalent of 100 mg was dissolved, diluted, and filtered. Absorbance was measured at 232 nm with water as blank.

 

For dissolution testing, Conducted in 1000 mL phosphate buffer (pH 6.8) at 37 ± 0.5 °C, 100 rpm (paddle). Samples were collected at 15 min, 1 h, 3 h, 5 h, and 8 h, diluted, filtered, and analyzed at 232 nm. The standard solution was prepared as per assay.

 

Glimepiride (HPLC):

Chromatographic Conditions:

·       Column: Inertsil ODS, 150 x 4.6 mm, 5 µm

·       Wavelength: 228 nm

·       Injection Volume: 10 µl

·       Flow Rate: 1.0 ml/min

·       Mobile Phase: 50:50 buffer: acetonitrile

·       Diluent: 90:10 acetonitrile: water

 

The assay for Glimepiride - A 10 mg IPRS standard was dissolved in 70 mL diluent, sonicated, diluted to 100 mL, and filtered (0.45 µm PVDF). For the sample, 20 tablets were powdered, and an amount equivalent to 10 mg was dispersed in solvent to prepare a 0.01% w/v solution, then filtered. Injections were run in the sequence: blank → standard → sample → bracketing standard. System suitability criteria: theoretical plates ≥2000, tailing factor ≤2.0, RSD ≤2.0%.

 

For dissolution testing, conducted in 900 mL phosphate buffer (pH 7.8) using a paddle at 75 rpm, 37 ± 0.5 °C. A 125 mg IPRS standard was prepared in solvent mixture (90:10 acetonitrile: water), diluted, and filtered. Samples were taken at 30 min, diluted, filtered, and analyzed, with blank, standard, and sample injections used to quantify dissolved drug.

 

Applied methods to compare dissolution profiles:

Statistical Analysis (ANOVA and t-tests)

 

Analysis of Variance (ANOVA):

·       ANOVA was used to test whether mean differences among groups were statistically significant.

 

t-tests:

·       These were utilised to compare the means between two groups. Both ANOVA and t-tests were done using [MS Excel 2019], with significance levels set at p < 0.05.

 

Model Independent Methods (Non-Mathematical Models: f1, f2, Rescigno ratio).

 

f1 (Difference Factor):

f2 (Similarity Factor):

f2=50×log {[1+  (Rt−Tt)2] −0.5×100}

Rescigno Ratio ζ1

 

Rescigno Ratio ζ2

 

where:

·       Di,T, and Di,R are the Dissolution values at time i for test and reference products.

·       dDi,T/dt  and dDi,R/dt are the Dissolution values at time i for test and reference products.

·       A ratio close to 1 indicates that the test and reference products have similar release profiles.

 

EXPERIMENTAL:

Metformin hydrochloride and glimepiride tablets were analyzed using UV spectroscopy and HPLC to compare branded and generic formulations.

·       Metformin: Assayed at 232 nm by UV; dissolution tested in 1000 mL phosphate buffer (pH 6.8) at 37 °C, 100 rpm, with samples taken up to 8 h.

·       Glimepiride: Quantified by HPLC (Inertsil ODS column, 50:50 buffer–acetonitrile); dissolution in 900 mL phosphate buffer (pH 7.8) at 37 °C, 75 rpm, sampled at 30 min.

 

3. RESULTS and DISCUSSION:

The study compared branded and generic Metformin HCl prolonged-release and Glimepiride tablets using UV spectroscopy, HPLC, and in-vitro dissolution tests, providing insights into quality, dissolution, and bioequivalence across formulations

 

3.1. Metformin Hydrochloride Prolonged Release 500 mg:

At 0.25 h, references were similar (R1: 17.78%, R2: 18.98), while generics varied (T1 highest 21.51%, T6 lowest 15.17%).

 

Early time point (1 hour): The dissolution values for R1 and R2 remained close (36.13% and 35.67%, respectively), with T2 and T3 nearly matching the reference profiles, whereas T5 and T6 showed lower dissolution values.

·       Mid time point (3 hours): At this point, branded samples were similar (R1: 48.32%, R2: 47.81), while generics, especially T2 (59.79%) and T3 (60.19%), showed higher dissolution, indicating faster release.

·       Later time point (5 hours): Branded samples remained consistent, while generics showed higher solubility, with T4 highest (73.67%).

·       Final time point (8 hours): Dissolution of branded and generics converged, with all nearing reference levels except T3, which stayed slightly lower.

All samples met pharmacopoeial standards (API 90 -110%). Both branded and generic forms released >85% within 8 h, confirming consistent efficacy.

 

3.2. Glimepiride 1 mg:

Statistical Analysis:

·       Model-independent techniques: f1 and f2 confirmed similarity between generic and branded profiles, while Rescigno ratios supported the closeness of their release characteristics.

·       Model-based approaches: Dissolution data were fitted to various models; First Order, Higuchi, and Korsmeyer-Peppas gave the best fit, indicating a complex release mechanism involving diffusion and polymer relaxation.

 

ANOVA and t Tests:

ANOVA showed significant changes in release over time, confirming sustained release. Pairwise t-tests found no significant differences between test and reference profiles, supporting therapeutic similarity.

 

4. CONCLUSION:

This study highlights the importance of rigorous analysis to ensure the quality and efficacy of anti-diabetic drugs, focusing on metformin prolonged-release and glimepiride. Branded and generic formulations were compared using UV spectroscopy, HPLC, and in-vitro dissolution testing. Drug release kinetics were evaluated with model-dependent (Zero Order, First Order, Higuchi, Korsmeyer-Peppas, Hixson-Crowell, Baker-Lonsdale) and model-independent (f₁, f₂, Rescigno ratio) approaches. Results showed time-dependent differences in dissolution affecting bioavailability, validated through ANOVA and t-tests. The findings support the reliability of generic formulations and underline the need for thorough evaluation to strengthen diabetes management.

 

5. LIST OF ABBREVIATIONS:

1.     T2DM - Type 2 Diabetes Mellitus

2.     HPLC - High-Performance Liquid Chromatography

3.     API - Active Pharmaceutical Ingredient

4.     SR - Sustained Release

5.     XR - Extended Release

6.     USP - United States Pharmacopeia

7.     IPRS - Indian Pharmacopoeia Reference Standard

8.     PVDF - Polyvinylidene Fluoride

9.     NMR - Nuclear Magnetic Resonance

 

 

6. CONFLICT OF INTEREST:

The authors declare no financial or personal conflicts of interest. The study was conducted without external funding, and the authors take full responsibility for the results.

 

7. ACKNOWLEDGEMENTS:

My special thanks to the Indian Pharmacopoeia Commission, which has generously assisted me both with resources and moral support, thus performing a great role in the successful completion of this work.

 

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Received on 03.08.2025      Revised on 05.12.2025

Accepted on 02.03.2026      Published on 01.07.2026

Available online from July 04, 2026

Research J. Pharmacy and Technology. 2026;19(7):2926-2932.

DOI: 10.52711/0974-360X.2026.00417

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