Analytical method for the simultaneous estimation of Benzthiazide and Triamterene in pure form and its pharmaceutical dosage form

Abstract

The primary objective of proposed work is developed new simple, sensitive, accurate and economical analytical

method for the simultaneous estimation of Benzthiazide and Triamterene in pure form and its pharmaceutical dosage

form. Also validate the proposed method in accordance with USP and ICH guidelines for the intended analytical

application i.e., to apply the proposed method for analysis of the Benzthiazide and Triamterene in dosage form. In

the present investigation, a simple, sensitive, precise and accurate RP-HPLC method was developed for the

quantitative estimation of Benzthiazide and Triamterene in bulk drug and pharmaceutical dosage forms. The

analytical method was developed by studying different parameters. Maximum absorbance was found to be at 238 nm and

the peak purity was excellent. Injection volume was selected to be 20µl which gave a good peak area. The column used for

study was Develosil C18 (4.6mm×250mm) 5µm particle size Column because it was giving good peak. Ambient

temperatures were found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0ml/min because of

good peak area and satisfactory retention time. Mobile phase is acetonitrile and acetate buffer (pH-4.3) (35:65% v/v) was

fixed due to good symmetrical peak. So this mobile phase was used for the proposed study. Run time was selected to be 6

min because analyze gave peak around 2.179, 3.610 ±0.02 min respectively and to reduce the total run time. The percent

recovery was found to be 98.0-102% was linear and precise over the same range. Both system and method precision was

found to be accurate and well within range. The analytical method was found linearity over the range 10-30mg/ml of

Benzthiazide and 30-90mg/ml of Triamterene of the target concentration. The analytical passed both robustness and

ruggedness tests. On both cases, relative standard deviation was well satisfactory.