Volume : 13, Issue : 08, August – 2026

Title:

SIMULTANEOUS ESTIMATION OF NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF DAPALIFLOZIN AND VILDAGLIPTIN BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Authors :

Palla Sushma*, Dr. Rama Krishna Mungi

Abstract :

A systematic analytical method development approach based on Design of Experiments (DoE) was employed for the simultaneous quantification of Dapagliflozin and Vildagliptin by Reverse Phase High-Performance Liquid Chromatography (RP-HPLC). Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, are widely used in combination therapy for the management of type 2 diabetes mellitus. The objective of the present study was to develop a robust, accurate, and precise RP-HPLC method using a Quality by Design (QbD) framework. Critical method parameters such as mobile phase composition, flow rate, and pH were systematically optimized using factorial design to evaluate their impact on critical quality attributes including retention time, peak area, resolution, and tailing factor. Chromatographic separation was achieved using a C18 column with an optimized mobile phase under isocratic conditions and UV detection. The developed method was validated according to ICH guidelines for specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). The method demonstrated excellent linearity over the selected concentration ranges for both analytes with satisfactory recovery and precision. Statistical analysis confirmed the significance of selected factors and their interactions, ensuring method robustness. The proposed DoE-based RP-HPLC method is simple, rapid, cost-effective, and suitable for routine quality control analysis of combined pharmaceutical dosage forms containing Dapagliflozin and Vildagliptin.
Keywords: Dapagliflozin; Vildagliptin; RP-HPLC; Design of Experiments (DoE); Quality by Design (QbD); Method Development; Simultaneous Estimation; Analytical Validation; Factorial Design; Pharmaceutical Analysis.

Cite This Article:

Please cite this article in press Palla Sushma et al., Simultaneous estimation of new analytical method development and validation of Dapaliflozin and Vildagliptin by high performance liquid chromatography. Indo Am. J. P. Sci, 2026; 13(08).

REFERENCES:

1. Rao BV, Sowjanya GN, Ajitha A, Rao Uma MV. A review on stability-indicating HPLC method development, World journal of pharmacy and pharmaceutical sciences, 2015; 4(8): 405-423.
2. Rajan HV. Development and validation of HPLC method – A Review. International Journal of current research in pharmacy, 2015; 1(2): 55-68.
3. Kumar V, Bharadwaj R, Gupta G, Kumar S. An Overview on HPLC Method Development, Optimization and Validation process for drug analysis. The Pharmaceutical and Chemical Journal, 2015; 2(2): 30-40.
4. B.V. Rao, G.N. Sowjanya1, A. Ajitha, V.U.M. Rao, Review on stability indicating hplc method development, World Journal of Pharmacy and Pharmaceutical Sciences, 2015; 4(8): 405-423.
5. Arpino, Patrick. Combined liquid chromatography mass spectrometry. Part III. Applications of thermo spray”. Mass Spectrometry Reviews, 1992; 11: 3. doi:10.1002/mas.1280110103.
6. Arpino, Patrick. Combined liquid chromatography mass spectrometry. Part I. Coupling by means of a moving belt interface”. Mass Spectrometry Reviews, 1989; 8: 35. doi:10.1002/mas.1280080103.
7. Gupta V, Jain AD, Gill NS, Gupta K. Development and validation of HPLC method – a review. International Research Journal of Pharmaceutical and Applied Sciences, 2012; 2(4): 17-25.
8. Sonia K, Nappinnai M. Development and validation of HPLC and UV-visible spectrophotometric method for the pharmaceutical dosage form and biological fluid –review. European Journal of Biomedical and Pharmaceutical sciences, 2016; 3(3): 382-391.
9. Sánchez MLF. Chromatographic techniques, European RTN Project, GLADNET, retrieved on, 05-09- 2013.
10. Mcpolin Oona. An Introduction to HPLC for Pharmaceutical Analysis. Mourne Training Service, 11-12.
11. United States Pharmacopoeia and National Formulary, (24th) Asian Edition, The United States Pharmacopoeia Convention Inc. U.S.A. 2126.
12. Sankar SR, Text book of Pharmaceutical Analysis. 5thEdition 2006. Rx publications, Tirunelveli, 2006; 13- 1,2.
13. M.S. Charde, A.S. Welankiwar, J. Kumar, Method development by liquid chromatography with validation, International Journal of Pharmaceutical Chemistry, 04(02): 57-61.
14. M.W. Dong, Modern Hplc for practicing scientists, John Wiley & Sons, New Jersey, 2006. 15. C.K. Kaushal, B. Srivastava, A process of method development: A chromatographic approach, J. Chem. Pharm. Res., 2010; 2(2): 519-545.

Volume : 13, Issue : 08, August – 2026

Title:

EVALUATION OF ANTIHYPERLIPIDEMIC ACTIVITY OF SAPINDUS EMARGINATUS IN RATS

Authors :

Chinthala Jamima*, Dr.R.narasimha Rao, Dr.N. Raghunandhan

Abstract :

Obesity and hyperlipidemia have become major disorders predominantly causing prevailing cardiovascular diseases and ultimately death. The prolonged use of anti-obesity drugs and statins for reducing obesity and blood lipid levels is leading toward adverse effects of kidneys and muscles, specifically rhabdomyolysis. The objective of this study is to evaluate potential of seeds of Sapindus emarginatus against hyperlipidemia. In this model of Hyperlipidemia, 30 adult male wistar rats (200-250gms) were evenly divided into 5 groups in both groups. Group-1 and Group-2 served as untreated and model controls respectively, while Group-3, 4 and 5 were the treatments groups which were simultaneously treated with standard, 100 and 200 mg/kg extract respectively along with High Fat Diet. On last day, blood samples for biochemical parameters, were obtained under inhaled diether anaesthesia. The outcomes of this study were expressed as mean standard error and data were evaluated by using analysis of variance followed by multiple comparisons. Oral administration of 100 mg/ kg and 200mg/kg body weight of Methanolic extract residual fraction of Moringa oleifera. Leaves exhibited a significant reduction (P < 0.01) in serum lipid parameters such as triglycerides, total cholesterol, low density lipoprotein (LDL), very LDL and increase in high density lipoprotein in hyperlipidemic rats when compared with hyperlipidemic control in both models. Our results demonstrated that Methanolic extract fraction of Sesbania grandiflora. Possessed significant antihyperlipidemic activity.
Keywords: Sesbania grandiflora, Cholesterol, LDL, triglycerides and antihyperlipidemic activity.

Cite This Article:

Please cite this article in press Chinthala Jamimaet al., Evaluation of Antihyperlipidemic activity of Sapindus Emarginatus in rats,, Indo Am. J. P. Sci, 2026; 13(08).

REFERENCES:

1. Amit G, Vandana S, Sidharth M. HYPERLIPIDEMIA: An Updated Review. Inter J of Biopharma & Toxicol Res 2011;1:81-89.
2. Virchow RP, Thrombose IG. In Gesammelte Abhandlungen zur Wissenschaftlichen Medicin. Frankfurt-am-Main, Meidinger Sohn & Company 1856, S 458-564.
3. Ankur rohilla, Nidhi Dagar, Seema Rohilla, Amarjeet Dahiya, Ashok Kushnoor. HYPERLIPIDEMIA- a deadly pathological condition. Inter J Curr Pharma Res 2012;4:15-18
4. Ross R, Glomset JA. The pathogenesis of atherosclerosis. N Engl J Med 1976;295:369-77.
5. Grundy SM, Vega GL. Hypertriglyceridemia: causes and relation to coronary heart disease – Semin. Thromb. Hemost 1988;14:249-64.
6. Dargel R. Lipoproteins and the etiopathogenesis of atherosclerosis. Zentralbl Allg Pathol 1989; 135: 501-504.