Aim:Three simple, accurate, and reproducible spectrophotometric methods have been developed and validated for simultaneous estimation of telmisartan (TELM) atorvastatin (ATV) in combined tablet dosage form.Materials and Methods:The first method is based on first-order derivative spectroscopy. The sampling wavelengths were 223 nm (zero crossing of TELM) where ATV showed considerable absorbance and 272 nm (zero crossing of ATV) where TELM showed considerable absorbance. The second method Q-analysis (absorbance ratio), involves formation of Q-absorbance equation using respective absorptivity values at 280.9 nm (isobestic point) and 296.0 nm (λmax of TELM). The third method involves determination using multicomponent mode method; sampling wavelengths selected were 296.0 and 246.9 nm.Results:TELM and ATV followed linearity in the concentration range of 5–40 and 4–32 μg/ml for method I, 5–30 μg/ml and 2–24 μg/ml for method II and III, respectively. Mean recoveries for all three methods were found satisfactory. All methods were validated according to International Conference on Harmonization Q2B guidelines.Conclusion:The developed methods are simple, precise, rugged, and economical. The utility of methods has been demonstrated by analysis of commercially available tablet dosage form.

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 rapid, precise, sensitive, economical, and validated high performance thin layer chromatographic method is developed for simultaneous quantification of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form. The method used amlodipine as internal standard (IS). Chromatographic separations were achieved on silica gel 60 F254 plates using toluene-methanol-ethyl acetate-acetone (2.5 : 1 : 0.5 : 2, v/v/v/v) as mobile phase. Densitometric analysis was carried out in the reflectance mode at 258 nm. Calibration curves were linear over a range of 80–480 ng/band for olmesartan medoxomil and 25–150 ng/band for hydrochlorothiazide. The detection and quantification limits were found to be 18.12 and 56.35 ng/band for olmesartan medoxomil and 6.31 and 18.56 ng/band for hydrochlorothiazide, respectively. Intra- and interassay precision provided relative standard deviations lower than 2% for both analytes. Recovery from 99.60 to 101.22% for olmesartan medoxomil and 98.30 to 99.32% for hydrochlorothiazide show good accuracy. Both the drugs were also subjected to acid, alkali, oxidation, heat, and photodegradation studies. The degradation products obtained were well resolved from pure drugs with significantly different R f values. As the method could effectively separate the drugs from their degradation products, it can be used for stability-indicating analysis. Validation of the method was carried out as per international conference on harmonization (ICH) guidelines.

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