Paper Type |
:: |
Research Paper |
Title |
:: |
Column selection considerations in HPLC method transfer for related substances of acetylsalicylic acid in tablets |
Country |
:: |
Macedonia |
Authors |
:: |
Katerina Stojmenova, Marija Zafirova Gjorgievska, Gabriela Petrovska-Dimitrievska, Olga Gigopulu, Natalija Nakov, Katerina Brezovska, Jasmina Tonikj Ribarska |
Page No. |
:: |
01-04 |
Analytical methods for the quality control of pharmaceutical raw materials and finished products are routinely transferred between laboratories, including contract research organizations and competent authority/official medicines control laboratories (OMCLs) equipped with diverse instrumentation. Successful method transfer is essential to ensure reproducible results, regulatory compliance, and consistent product quality, while minimizing the need for partial or full method re-validation. Reversed-phase high-performance liquid chromatography (RP-HPLC) remains the dominant separation technique, accounting for more than 90% of chromatographic applications..........
Keywords : RP-HPLC; Method transfer; Related substances; Acetylsalicylic acid; Column selection.
[1].
United States Pharmacopeia and National Formulary (USP-NF). Chapter <1224>, Transfer of Analytical Procedures, www.usp.org accessed 10-Fev-2026. DOI: https://doi.org/10.31003/USPNF_M5511_04_01.
[2].
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2023). ICH Q2(R2) guideline: Validation of analytical procedures. https://database.ich.org.
[3].
Žuvela, P., Skoczylas, M., Liu, J. J., Ba̧czek, T., Kaliszan, R., Wong, M. W., & Buszewski, B. (2019). Column characterization and selection systems in reversed-phase high-performance liquid chromatography. Chemical Reviews, 119(6), 3674–3729. https://doi.org/10.1021/acs.chemrev.8b00246.
[4].
Snyder, L. R., Kirkland, J. J., & Dolan, J. W. (2011). Introduction to modern liquid chromatography (3rd ed.). John Wiley & Sons.
[5].
European Pharmacopoeia (Ph. Eur.). Chapter 2.2.46. Chromatographic separation techniques. 12th ed. Online version 12.2, www.edqm.eu accessed 10-Feb-2026.
Paper Type |
:: |
Research Paper |
Title |
:: |
Comparative Efficacy of ACE inhibitors and ARBs in Patients with Type 2 Diabetes Mellitus and Hypertension: Effects on Blood Pressure and Renal Outcomes |
Country |
:: |
India |
Authors |
:: |
Rammohan B, Sunanda B.P.V, Abhay Kumar John, Dhastagir Sultan Sheriff |
Page No. |
:: |
05-08 |
Background: Diabetic patients with high risk of end-stage renal failure due to albuminuria and death; ACEIs and ARBs are commonly used however comparative benefits remain unknown. Methods: 100 adults (≥18 years) with T2DM (Hb1c ≥6.5%),and with hypertension initiating ACEI (e.g., enalapril) or ARB (e.g., losaran) monotherapy (eGFR 30-90 mL/min/1.73m2), exclusions: prior RAS use, pregnancy, hyperkalemia. Baseline data (BP,eGFR, ACR, HbA1c) were analysed in the present prospective study (from clinic records; 24-month follow-up quarterly)...........
Keywords : ACEIs, ARBs, type 2 diabetes, hypertension, renal outcomes, blood pressure, albuminuria.
[1].
International Diabetes Federation. IDF Diabetes Atlas, 10th ed. Brussels, Belgium: International Diabetes Federation; 2021.
[2].
American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2024;47(suppl 1): S144-S15. DOI: 10.2337/dc24.S010
[3].
International Diabetes Federation. IDF Diabetes Atlas (9th Edition). International Diabetes Federation,2019.
[4].
Zheng, Y., Ley, S. H., & Hu, F. B. Global Aetiology and Epidemiology of Type 2 Diabetes and its Cardiovascular Consequences: Current Perspectives. Nature Reviews Cardiology, 2018;15: 536–546. DOI: 10.1038/s41569-018-0040-7
[5].
Tahir F, Rizvi SA, Akhtar FN. Comparison of efficacy of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in delaying diabetic nephropathy. Pakistan Armed Forces Medical journal. 2025;75:258-261. DOI: 10.51253/pafmj.v75i2.9146
©All Rights Reserved | Design by iosrphr