Direct Spectrophotometric Determination of Perindopril Erbumine and Enalapril Maleate in Pure and Pharmaceutical Dosage Forms using Bromocresol Green

In this article, it has been reported new, simple, sensitive and direct spectrophotometric methods for the determination of Perindopril Erbumine (PPE) and Enalapril Maleate (ENL) in pure and in pharmaceutical forms. Spectrophotometric methods are based on the formation of yellow colored ion-pair complexes between PPE, ENL and sulphonphthalein acid dye, Bromocresol green (BCG) into chloroform were measured at the wavelength of 414 and 415nm for PPE and ENL, respectively. The optimal analytical conditions were determined. The obtained complexes (BCG: PPE) and (BCG: ENL) reached maximum absorbance directly after formation at room temperature for a stability period of 24 h. Beer’s law were obeyed in the concentration ranges of (2-20)µg/mL for PPE and (8- 44)µg/mL for ENL, the limit of detection of 0.125μg/mL and 0.230μg/mL were found for PPE and ENL, respectively. The molar absorptivity coefficients were 4.4045*104 L.moL-1.cm-1 for PPE and 1,9330*104 L.moL-1.cm-1 for ENL. The stoichiometry of the complexes formed between PPE, ENL and BCG were 1:1. No interference was observed from common excipients occurred in pharmaceutical formulations and the proposed methods have been successfully applied to determine the PPE and ENL in some pharmaceutical products and in ENL combination dosage forms with hydrochlorothiazide (HCTZ). The proposed methods were successfully validated to be utilized in the quantitative analysis of PPE and ENL in their pure and pharmaceutical products. A good agreement between the developed spectrophotometric methods with the results obtained from official reference methods for the determination of the two drugs in some real samples demonstrate that the proposed methods were suitable to quantify PPE and ENL in pharmaceutical formulations.

A new RP–HPLC method for simultaneous quantification of perindopril erbumine, indapamide, and amlodipine besylate in bulk and pharmaceutical dosage form

Background Perindopril erbumine is a specific inhibitor of angiotensin-converting enzyme, indapamide is the one providing thiazide diuretic effect, and amlodipine besylate is a calcium antagonist which belongs to the dihydropyridines which helps to maintain the pressure of the blood in the patient having arterial hypertension. The literature survey discloses that only one method is available for the estimation of the combination in the quantitative analytical liquid chromatographic method. Moreover to this, the literature review also reveals that HPTLC, UV spectroscopy, and HPLC methods are available for the analysis of either of the two in combination. Hence, our area of interest is to develop and validate the RP-HPLC in order to quantify perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and formulation. Result Sensitive and accurate RP-HPLC method was developed for the simultaneous estimation of indapamide, perindopril erbumine, and amlodipine besylate in bulk and available as triplixam-marketed tablet dosage form which is a combination of these drugs. The Phenomenex C-18 column (250 mm × 4.6 mm, 5 μm) was used as a stationary phase, and acetonitrile: methanol: water (30:20:50, v/v/v) was found to be optimized mobile phase which was further adjusted to pH 3.0 by utilizing 1.0% orthophosphoric acid; the flow rate kept was 1 ml/min and experiments were performed using PDA detector. The common detection wavelength for all the three APIs was found to be 215.0 nm. The method was validated as per ICH Q2 (R1). The linearity range for amlodipine besylate was found to be 0.500–9.500 μg/ml; for perindopril erbumine was found to be 0.400–7.600 μg/ml, and for indapamide was found to be 0.125–2.375 μg/ml. The correlation coefficient was found to be more than 0.9975 for all three of them, whereas the mean percentage recovery was found to be 99.52–100.71%, 99.49–100.89%, and 99.90–100.78%, respectively. Conclusion The proposed RP-HPLC method is found to be accurate and robust enough to estimate the perindopril erbumine, indapamide, and amlodipine besylate simultaneously in bulk and available tablet dosage form of combination.

Analytical techniques for estimation of Perindopril Erbumine: A review

Aims: According to Matthew R Alexander, MD, PhD Fellow, Division of Cardiovascular Medicine, Department of Internal Medicine, Physician Scientist Training Program, Vanderbilt University School of Medicine, have written in a article that an estimated 26% of the world’s population (972 million people) has hypertension, and the prevalence is expected to increase to 29% by 2025, driven largely by increases in economically developing nations. So many new drugs are developed for its treatment. Perindopril erbumine is a one of the ACE inhibitor for treating hypertension and heart failure. Background: Perindopril is officially listed in USP, BP and EP. There are number of methods reported for its estimation. Objective: Objective of this review article is to include various analytical techniques used for its estimation in bulk, dosage form or any bilological fluids. Method: This paper includes various analytical techniques like UV-spectroscopic method, stability indicating liquid chromatography method, Thermo-Radio and Photo stability study, Stability indicating UHPLC-DAD method, LC-MS/MS electro spray ionization validated method, LC-MS/MS bio-analytical method, Thin layer chroamtography and many more. Result: This paper has included all different analytical techniques used for estimation of Perindropril. Conclusion: In this review, we summarized the analytical detection techniques used in identification, quantification of perindopril erbumine as well as its related substances. The Spectroscopy and RP-HPLC methods are widely applied for activity determination of perindopril erbumine as well as its related substances in pharmaceutical dosage forms. This all techniques can be precisely applied on Perindopril erbumine. Other: There is still scope for the development of new selective and specific analytical techniques for quantization of this drug.