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ABSTRACT:
A selective and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the separation and quantification of telmisartan and indapamide in capsule dosages form has been fist developed and validated. Quantification carried out using Stainless Steel C18 130 x 4.6, 5µm column as a stationary phase and mobile phase comprised of 50mM KH2PO4, Acetonitrile and methanol in proportion of 50:20:30 (v/v/v) with pH adjusted to 3.0 ± 0.1 by using o-phosphoric acid. The flow rate was 1.0 ml/min and monitored at 280 nm. The retention time for telmisartan and indapamide were 11.1 and 4.458 minutes, respectively. The method was validated in terms of linearity, precision, accuracy, ruggedness, and specificity, limit of detection and limit of quantification. The linearity (r2) and percentage recoveries of telmisartan and indapamide were 0.9998 and 99.85 µg/ml and 0.9988 and 99.91 % respectively. The proposed method is suitable for simultaneous determination of telmisartan and indapamide in capsule dosage form.
KEYWORDS: RP-HPLC; Telmisartan; Indapamide; simultaneous determination.
1. INTRODUCTION:
Telmisartan, 2-(4-{[4-methyl-6-(1-methyl-1H-1,3- benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl] methyl} phenyl) benzoic acid, is a white crystalline powder, slightly soluble in water but freely soluble in alcohol and 1N NaOH solution. Telmisartan is an angiotensin II receptor antagonist used for hypertension. Indapamide is a benzamide- Sulfonamide-indole. It is a thiazide-like diuretic and it is used as an antihypertensive and a diuretic. Chemically it is known as 4-chloro-N-(2-methyl-2,3- dihydroindol-1-yl)-3-sulfamoyl-benzamide. Even though various methods reported in the literature for estimation of Telmisartan1-9 and Indapamide10-17 individual or in combination with other drugs no method had been reported so far for simultaneous estimation of these two drugs using HPLC in capsule dosage forms. The present study was aimed at the simultaneous estimation of telmisartan and indapamide by HPLC method. This method was validated according to the ICH guidelines19.
2. EXPERIMENTAL:
2.1. Instrument:
A HPLC (LC-20AD, Shimadzu, Japan) connected to computer loaded with spinchrom chromatographic software. System was coupled with SPD-20A prominence UV/Vis detector. All weights were taken on semi microbalance (Shimadzu -AX -200 electronic balances)
2.2. Reagents and chemicals;
Telmisartan and Indapamide were obtained as giftsample from Zydus Cadila Healthcare Ltd., Ahmedabad (Gujarat). Potassium dihydrogen phosphate, and potassium hydroxide were A.R. grade from Merck chemicals Mumbai, India. Acetonitrile and milli Q water were HPLC grade supplied by...