Analytical method development and validation for simultaneous estimation of amlodipine besylate and perindopril arginine in combined pharmaceutical dosage form

Bhagirath K. Patel, Subhaschandra K. Patel, Swati R. Patel

Abstract


Objective: A simple, accurate, precise and sensitive Reversed Phase High Performance Liquid Chromatography (RP-HPLC) method was developed for simultaneous estimation of amlodipine besylate and Perindopril arginine in combined pharmaceutical dosage form.

Methods: Using C18 (250 mm × 4.6 mm i.d., 5µm) column and phosphate Buffer (pH 5.0): Acetonitrile (70:30 v/v) as mobile phase at Flow Rate 1.0 ml/min with Detection Wavelength 240 nm. Retention time in RP-HPLC was found to be 10 min. The method was validated in term of accuracy, precision, linearity, limit of detection, limit of quantitation and robustness as per International Conference of harmonization (ICH) guidelines.

Results: For RP-HPLC linearity were found in range of 20 µg/ml and 10 µg/ml, respectively. Retention times in RP-HPLC were found to be 3.243 min and 7.110 min for Perindopril Arginine and Amlodipine Basylate and optimized chromatographic condition. The linearity and range data for Amlodipine Basylate and Perindopril Arginine was found to be 0.998 and 0.997 Respectively. The precision data for Perindopril Arginine and Amlodipine Basylate was found to be 0.816 and 1.063 respectively. The accuracy of the present method was evaluated at 80%, 100% and 120%. The Accuracy data for Perindopril Arginine was 99.72-100.02%, while for Amlodipine Basylate, it was found to be in range of 99.87-100.17%. LOD value was found to be 3.3 for Amlodipine Basylate-0.700 µg/ml and Perindopril Arginine - 0.564 µg/ml respectively. LOQ value was found to be 10 for The method was found to be Amlodipine Basylate 2.121 µg/ml and Perindopril Arginine 1.709 µg/ml.

Conclusions: This method can be used to utilize for routine laboratory analysis and assay of Amlodipine Basylate and Perindopril Arginine in their combined dosage form.

Keywords


RP-HPLC, Amlodipine besylate, Perindropril arginine, ICH guidelines

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References


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