Abstract

ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND AMLODIPINE BESYLATE: A COMPREHENSIVE REVIEW

Vijay Rathore, Arjun Parmar*, Mangal Singh Panwar

ABSTRACT

Telmisartan and amlodipine besylate have been broadly utilized in blend to treat hypertension and are accessible in various blend pharmaceutical items. Accurate analytical techniques are required for the identification, quantification, quality control and stability testing of these drugs. The analytical techniques reported for simultaneous estimation of Telmisartan with Amlodipine besylate is summarized in this review and special attention is paid to reverse phase high performance liquid chromatography (RP-HPLC). A number of analytical techniques such as UV-visible spectrophotometry, HPTLC, RP-HPLC, LC-MS/MS, UPLC and q¹H-NMR, are discussed in terms of the chromatographic conditions, detection parameters, validation characteristics, and application. Reported RP HPLC methods were mostly focused on C18 column, using appropriate aqueous-organic mobile phases and UV detection, showing its feasibility for routine analysis of combined dosage forms of RP. Important method-development considerations and stability-indicating methods are also discussed. The importance of ICH Q2(R2) and ICH Q14 guidelines, analytical quality by design (AQbD), design of experiments (DoE) and green analytical approaches for modern analytical method development is emphasized. The review offers a single summary of the current analytical methods available and could help researchers choose appropriate methods for analyzing and evaluating the quality of telmisartan and amlodipine besylate formulations.

Keywords: Telmisartan; Amlodipine besylate; RP-HPLC; Analytical method development; Method validation; HPTLC; LC-MS/MS; Stability-indicating method; AQbD.