Development and Validation of Stability Indicating HPTLC and HPLC Methods for Simultaneous Determination of Telmisartan and Atorvastatin in Their Formulations

Abstract

The present study describes development and subsequent validation of stability indicating HPLC and HPTLC methods for simultaneous estimation of Telmisartan (TLM) and Atorvastatin (ATV) in their combined formulation. The proposed RP-HPLC method utilizes a Phenomenex Luna C 18 column using acetonitrile: 0.025 M ammonium acetate (38 : 52%, v/v) as mobile phase (pH 3.8), flow rate of 1.0 mL/min. Quantification was achieved with UV detection at 281 nm over concentration range of 12 to 72 g/mL for TLM and 3 to 18 g/mL for ATV respectively. In HPTLC, separations were performed on silica gel 60 F 254 using toluenemethanol-ethyl acetate-acetic acid (5 : 1 : 1 : 0.3, v/v) as mobile phase. The compact bands of TLM and ATV at 0.37 ± 0.02 and 0.63 ± 0.01 respectively were scanned at 279 nm. Linear regression analysis revealed linearity in the range of 40 to 240 ng/band for TLM and 10 to 60 ng/band for ATV respectively. For both the methods, dosage form was exposed to thermal, photolytic, acid, alkali and oxidative stress. The methods distinctly separated the drugs and degradation products even in actual samples. In conclusion, the proposed HPLC and HPTLC methods were appropriate for routine quantification of TLM and ATV in tablet formulation.

A Fast and Validated Reversed-Phase HPLC Method for Simultaneous Determination of Simvastatin, Atorvastatin, Telmisartan and Irbesartan in Bulk Drugs and Tablet Formulations

“…The methods based on high performance thin layer chromatography have also been reported for the determination of simvastatin in bulk drugs and marketed formulations [ 28 ]. Various methods are also available for the analysis of telmisartan in single dosage forms as well as in combinations with other drugs by UV-spectrophotometry [ 29 , 30 , 31 ] and liquid chromatographic techniques such as HPLC [ 32 , 33 ], HPTLC [ 34 , 35 ]and supercritical fluid chromatography [ 36 ]. Furthermore, several methods for the quantification of irbesartan in bulk drug and single as well as combined formulations have been reported by using UV-spectrophotometric [ 36 , 37 , 38 , 39 ] and HPLC [ 40 , 41 ] methods.…”

Analytical Method Development and Validation for the Simultaneous Estimation of Telmisartan and Atorvastatin in Bulk and Tablet Dosage Form

“…The present analytical method was validated as per the guidelines of ICH with reference to various factors like linearity, specificity, precision, accuracy, the limit of detection (LOD), the limit of quantitation (LOQ), and robustness. [9][10][11]…”

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“…Column: HibarC18 (250 mm x 4.6 mm ,5 μm) Mobile Phase: Ammonium Formate solution (pH 4.0): Methanol (70:30), v/v Flow Rate: 1 mL/min Wavelength: 275 nm Linearity: 0.1-1.5 (µg/ml) Retention Time: 3.7 min. 37…”