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 :

Gangula Shireesha *, Dr. Manjula Betholi

Abstract :

A simple, rapid, accurate, precise, and economical Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the simultaneous estimation of Azithromycin and Metronidazole in pharmaceutical dosage forms. The chromatographic separation was achieved using a suitable C18 column with an optimized mobile phase composition under isocratic conditions. Detection was carried out at an appropriate wavelength, providing satisfactory sensitivity for both analytes. The developed method resulted in well-resolved peaks with acceptable retention times, good peak symmetry, and satisfactory system suitability parameters. The method was validated according to International Council for Harmonisation guidelines for specificity, linearity, accuracy, precision, robustness, limit of detection (LOD), limit of quantification (LOQ), and system suitability. The calibration curves for both Azithromycin and Metronidazole showed good linearity within the selected concentration ranges, with correlation coefficients close to 1. Accuracy studies demonstrated satisfactory percentage recoveries, while precision studies showed low percentage relative standard deviation (%RSD), indicating the reliability and reproducibility of the method. The developed method was found to be specific, sensitive, and unaffected by common pharmaceutical excipients. The validated RP-HPLC method was successfully applied for the simultaneous quantitative estimation of Azithromycin and Metronidazole in pharmaceutical formulations. The results confirmed that the method is suitable for routine quality control analysis and can be effectively employed in pharmaceutical industries and analytical laboratories for the assay of these drugs.
Keywords: Azithromycin, Metronidazole, RP-HPLC, Method Development, Method Validation, Simultaneous Estimation, Pharmaceutical Dosage Forms, Quantitative Analysis, ICH Guidelines, Quality Control Analysis

Cite This Article:

Please cite this article in press Gangula Shireesha 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. Swartz ME, Jone MD, Fowler P, Andrew MA. Automated HPLC method development and transfer. LcGc N. Am, 75, 2002,49-50.
2. Synder LR, Kirkland JJ, Glajach JL. X. In Practical HPLC Methods Development. John Wiley, New York, 295, 1997,643-712.
3. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), P1-7.
4. A. BraithWait and F.J. Smith, Chromatographic Methods, 5thedition, Kluwer Academic Publisher, (1996), PP 1-2.
5. Andrea Weston and Phyllisr. Brown, HPLC Principle and Practice, 1st edition, Academic press, (1997), PP 24-37.
6. Yuri Kazakevich and Rosario Lobrutto, HPLC for Pharmaceutical Scientists, 1stedition, Wiley Interscience A JohnWiley & Sons, Inc., Publication, (2007), PP 15-23.
7. Chromatography, (online). URL: http://en.wikipedia.org/wiki/Chromatography.
8. Meyer V.R. Practical High-Performance Liquid Chromatography, 4thEd. England, John Wiley & Sons Ltd, (2004), PP 7-8.
9. Sahajwalla CG a new drug development, vol 141, Marcel Dekker Inc., New York, (2004), PP 421–426.
10. D. H. Shewiy, E. Kaale, P. G. Risha, B. Dejaegher, J. S. Verbeke, Y. V. Heyden, Journal Pharmaceut. Biomed. Anal, 66, 2012,11-23.
11. M. D. Rockville, General Tests, Chapter 621 – Chromatography System Suitability, United States Pharmacopeial Convention (USP), USP 31,2009.
12. FDA Guidance for Industry-Analytical Procedures and Method Validation, Chemistry, Manufacturing, and Controls Documentation, Center for Drug Evaluation and Research (CDER) and Centre for Biologics Evaluation and Research (CBER),2000.
13. Korany MA, Mahgoub H, Ossama TF, Hadir MM. Application of artificial neural networks for response surface modelling in HPLC method development. J Adv Res, 3, 2012,53-63.
14. Swartz M, Murphy MB. New Fronties in Chromatography. Am Lab, 37, 2005,22-27.
15. Dolan JW. Peak tailing and resolution. LcGc N. Am, 20, 2002,430-436.
16. Chan CC, Leo YC, Lam H. Analytical method validation and Instrument Performance Validation. Vol-I, Wiley Interscince,2004.
17. Shabir GA, Lough WJ., Arain SA, Bradshaw TK. Evaluation and application of best practice in analytical method validation. J Chromatogr RT, 30, 2007,311-333.
18. Miller JN, Miller JC, Statistics and chemometrics for analytical chemistry Harlow, Pearson Prentice Hall, 2005, 263.
19. Huber L. Validation of HPLC methods. Bio Pharm. Int, 12,1999,64-66.
20. European-commission Quality control procedures for pesticide residues analysis. Report number SANCO/10232/2006.

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.