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Method development and validation of RP-HPLC for the simultaneous estimation of escitalopram and etizolam in bulk and pharmaceutical dosage form

By: Vadrevu, S.
Contributor(s): Govindarao, K.
Publisher: Mumbai Indian Drug Manufacture's Association - IDMA 2018Edition: Vol. 55 (02) February.Description: 50-56.Subject(s): PHARMACEUTICS In: Indian drugsSummary: The developed RP-HPLC method allows rapid and precise determinations of escitalopram and etizolam in bulk and pharmaceutical dosage forms. The objective of the proposed method was to develop a simple and accurate method for the determination of escitalopram and etizolam by RP-HPLC method in pharmaceutical dosage forms & its stability indicative studies. A series of mobile phases were tried; among the various mobile phases , potassium dihydrogen phosphate buffer and dipotassium hydrogen phosphate 0.02 M, pH 3.0 : acetonitrile (20:80) is an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at less than 2 mL/min. The linearity and correlation coefficient of escitalopram and etizolam at 0-45μg/mL and 0-75μg/mL was found to be 0.998 & 0.998, respectively. The LOD was found to be 0.1 mg/mL and 0.3 mg/mL and LOQ was found to be 0.15 mg/mL and 0.45 mg/mL for escitalopram and etizolam, respectively, which represents that sensitivity of the method is high. The method was known to be accurate with the assay method. The % assay was found to be 100 % and 98%. The developed method showed a good accuracy and precision. The % RSD is for escitalopram and etizolam was found to be 1.50 and 1.22. This method shows good reproducibility of the results. Furthermore, this method was simple, sensitive, and accurate. Hence, the chromatographic method developed for escitalopram & eizolam can be effectively applied for routine analysis.
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The developed RP-HPLC method allows rapid and precise determinations of escitalopram and etizolam in bulk and pharmaceutical dosage forms. The objective of the proposed method was to develop a simple and accurate method for the determination of escitalopram and etizolam by RP-HPLC method in pharmaceutical dosage forms & its stability indicative studies. A series of mobile phases were tried; among the various mobile phases , potassium dihydrogen phosphate buffer and dipotassium hydrogen phosphate 0.02 M, pH 3.0 : acetonitrile (20:80) is an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at less than 2 mL/min. The linearity and correlation coefficient of escitalopram and etizolam at 0-45μg/mL and 0-75μg/mL was found to be 0.998 & 0.998, respectively. The LOD was found to be 0.1 mg/mL and 0.3 mg/mL and LOQ was found to be 0.15 mg/mL and 0.45 mg/mL for escitalopram and etizolam, respectively, which represents that sensitivity of the method is high. The method was known to be accurate with the assay method. The % assay was found to be 100 % and 98%. The developed method showed a good accuracy and precision. The % RSD is for escitalopram and etizolam was found to be 1.50 and 1.22. This method shows good reproducibility of the results. Furthermore, this method was simple, sensitive, and accurate. Hence, the chromatographic method developed for escitalopram & eizolam can be effectively applied for routine analysis.

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