A New Validated Stability-Indicating HPTLC Method for Simultaneous Determination of Telmisartan, Hydrochlorothiazide and Amlodipine in Oral Pharmaceutical Tablet Dosage Form
1, 1, 1, 1
- 1Department of Pharmaceutical Analysis, PESU Institute of Pharmacy, PES University, Electronic City Campus, Bengaluru, Karnataka, INDIA.
CORRESPONDENCE
Biswa Ranjan Patra
Department of Pharmaceutical Analysis, PESU Institute of Pharmacy, PES University, Electronic City Campus, Bengaluru, Karnataka, INDIA.
Volume 60, Issue 5 (KrupaPharmaCon 2026) · pp. 220-231 · 2026 · DOI: 10.5530/ijper.krupapharmacon.39
ABSTRACT
Background: The pharmaceutical preparation of Telmisartan, Hydrochlorothiazide, and Amlodipine is commonly employed in an anti-hypertension therapy, requiring dependable analytical techniques for quality evaluation.Objectives: This study focused on the development of an easy, fast, and also accurate stability-indicating High-Performance Thin-Layer Chromatography (HPTLC) analytical method for concurrent determination of Telmisartan, Hydrochlorothiazide, and Amlodipine for their bulk and tablet formulations.Materials and Methods: Separation was performed using pre-coated Silica gel 60 F254 TLC plates as stationary phase with Toluene: Chloroform: Methanol (2:5:2 v/v/v) as mobile phase. Conducted a Densitometric scanning at the wavelength of 265 nm for identification of spots. Stress testing recommended by the ICH was performed on the standard drugs of Telmisartan, Hydrochlorothiazide, and Amlodipine bulk formulations followed by quantification of the stressed substances with the proposed analytical method.Results: Three well-distinguished peaks were obtained for the drugs using the proposed method with retention factor values of 0.63±0.03, 0.32±0.03, and 0.13±0.03 for Telmisartan, Hydrochlorothiazide, and Amlodipine, respectively. Degradation study of the drugs was mainly perceived in acidic, alkaline, hydrolytic, and oxidative environments. The planned HPTLC technique was assessed according to the ICH guidelines with validation parameters including calibration behavior, trueness, repeatability, selectivity, and reliability falling within permissible limits.Conclusion: The developed HPTLC technique was found to be stability- assessing, making it preferable for the regular analysis as well as stability testing of the studied drugs in fixed dose combinations.
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Patra, B. R., Ramalingaiah, R. H., Krishna, S., & Kumar, R. A. (2026). A New Validated Stability-Indicating HPTLC Method for Simultaneous Determination of Telmisartan, Hydrochlorothiazide and Amlodipine in Oral Pharmaceutical Tablet Dosage Form. Indian Journal of Pharmaceutical Education and Research, 60(5), 220-231. https://doi.org/10.5530/ijper.krupapharmacon.39
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