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Aim: The aim of this work is to establish two simple, economical, and rapid spectrophotometric methods for the quantification of entacapone in bulk material and in tablets. Further, this study is designed to validate the developed methods as per ICH guidelines. Materials and Methods: In Methods I and II, a stock standard solution was prepared by dissolving 10 mg of entacapone in 100 mL of 10% v/v acetonitrile to obtain a concentration of 100 µg/mL. After suitable dilution, 10 µg/mL of entacapone was prepared and scanned in the UV-visible range 500-200 nm; entacapone showed a maximum absorbance at 384.40 nm. In Method I, area under curve (AUC) of the zero-order spectrum was recorded between 348.00 and 410.20 nm. While, in Method II, zero-order spectra were derivatized into first-order, and the AUC was recorded between 386.40 and 460.20 nm. For a linearity study, series of dilutions were prepared from stock solutions. Results: In Method I, and II, entacapone followed linearity in the concentration range of 2-12 µg/mL and 5-30 µg/mL with (r²>0.999). The amounts of entacapone estimated by both these methods were found to be 99.24 ± 0.054 and 98.68 ± 1.04, respectively. Conclusion: The developed methods are simple, precise, rugged, robust, and economical. Both these methods can be used for routine analysis of entacapone from its tablet formulation. [ABSTRACT FROM AUTHOR]

Aim: A simple, rapid, selective, accurate, and precise UV spectrophotometric method has been developed for the estimation of ethacridine lactate from bulk and pharmaceutical formulation. Materials and Methods: Appropriate aliquot portions of stock standard solution of ethacridine lactate were transferred into five separate 10 ml volumetric flasks, and the volume was adjusted to the mark with double distilled water to obtain concentrations of 0.2, 0.4, 0.6, 0.8, 1.0, and 1.2 µg/ml. The λmax of ethacridine lactate in double distill water was found to be 271 nm with an apparent molar absorptivity of 59.781 x 10³ l/mol cm. The drug follows linearity in the concentration range 2-12 µg/ml with a correlation coefficient value of 0.998. Results: The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.71% was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 80%, 100%, and 120%. The % recovery was found to be in the range 99.26-100.25%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as intraday, interday variations and repeatability. The % RSD value less than 2 indicates that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. Conclusion: The results indicated that the method could be used for the routine estimation of ethacridine lactate from tablet formulations. [ABSTRACT FROM AUTHOR]

A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for estimation of Ethacridine lactate in pharmaceutical formulation. The method was carried out on a Qualisil RP C-18 (250 mm x 4.6 mm, 5 µm) column with a mobile phase consisting of methanol: water (60:40 v/v), pH adjusted to 2.8 with orthophosphoric acid and low rate of 1.0 mL/min. Detection was carried out at 271 nm. The retention time for ethacridine lactate was found to be 4.41 min. The ethacridine lactate followed linearity in the concentration range of 2- 12 µg/mL (r² = 0.9980). The amount of the drug estimated by proposed method was found to be in good agreement with label claim. The developed method was validated for sensitivity, accuracy, precision, ruggedness and robustness. The LOD and LOQ were found to be 0.11 and 0.33 µg. The proposed method can be used for routine analysis of ethacridine lactate in bulk drug and pharmaceutical formulation. [ABSTRACT FROM AUTHOR]