Simultaneous quantification of perindopril erbumine, indapamide and amlodipine besylate in newer combination of anti‐hypertensive drugs in pharmaceutical dosage form by thin layer chromatography method

Patel, Kirtan; Chhalotiya, Usmangani K.; Kachhiya, Hetaben M.; Shah, Dimal A.; Nagda, Dhruti

doi:10.1002/sscp.202000010

Cited by 7 publications

(9 citation statements)

References 10 publications

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“…Apart from this, HPLC, HPTLC, and UV spectrophotometric techniques were only reported for the determination of these APIs either alone or in dual combinations . Moreover, this one HPTLC method was also found to quantify and estimate PER, IND, and AML simultaneously in bulk as well as a pharmaceutical formulation which is a tablet dosage form [28].…”

Section: Introductionmentioning

confidence: 94%

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

2020

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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.

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Section: Introductionmentioning

confidence: 94%

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

2020

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“…The literature review reveals that various analytical methods based on UV-spectrophotometry [5-7], HPLC [8][9][10][11][12][13][14][15][16], HPTLC [17][18][19][20], and LC-MS [21][22][23][24] have been developed for quantitative estimation of PER and MOX in pure drug or combination with other drugs as well as in pharmaceutical preparations.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of high‐performance thin layer chromatographic method for simultaneous quantitation of novel combination perindopril erbumine and moxonidine hydrochloride

Akabari

Surati

Patel

et al. 2023

Separation Science Plus

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The primary purpose of the present study was to develop and validate a high‐performance thin‐layer chromatography method for quantitatively determining an anti‐hypertensive agent, perindopril erbumine, and moxonidine hydrochloride in bulk and synthetic mixture. The densitometric procedure was performed on aluminum thin‐layer chromatography plates pre‐coated with silica gel 60F254, employing a combination of dichloromethane: toluene: methanol: ammonia (7:1:2:0.1 v/v/v/v) as the mobile phase. The thin‐layer chromatography scanner was operated in absorbance mode at a wavelength of 223 nm to evaluate densitograms. The linearity of the method was established in the range of 1000–5000 ng/band for perindopril erbumine and 40–200 ng/band for moxonidine hydrochloride; the correlation coefficient (r2) was 0.9993 and 0.9983, respectively. The values of a limit of detection (186.06 and 3.51 ng/band, respectively, for perindopril erbumine and moxonidine hydrochloride) and limit of quantification (620.23 and 11.73 ng/band, respectively, for perindopril erbumine and moxonidine hydrochloride) have demonstrated the sensitivity of the developed method. The reported process was precise in both intra‐day and inter‐day analysis; the percentage relative standard deviation of peak area was less than 2% and has an accuracy within 100 ± 2%. The developed method has the potential to quantify perindopril erbumine and moxonidine hydrochloride from its synthetic mixture without any interference from other components or in quality control laboratories.

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“…A new combination of AML, IND and PRN, with complementary activities, is used to control blood pressure in patients with arterial hypertension (Nedogoda & Stojanov, 2017; Scheen, Lancellotti, & Krzesinski, 2014). Several analytical methods have been described for simultaneous determination of AML, IND and PRN in pharmaceutical formulations (El‐Bagary, Elkady, Mowaka, & Attallah, 2017; Karadurmus, Gümüştaş, Kurbanoğlu, Uslu, & Özkan, 2018; Patel et al, 2020). Determination of AML in plasma alone or with other drugs was done by LC–MS/MS methods (Chen, Luan, Zhong, & Zong Min, 2001; Sathe, Venitz, & Lesko, 1999; Shah et al, 2017; Sirikatitham, Panrat, & Tanmanee, 2008; Streel, Lainé, Zimmer, Sibenaler, & Ceccato, 2002; B. Wang, Sheng, & Li, 2015; L. Wang, Liu, Zhang, & Tian, 2018; Wei, Yang, Qi, & Chen, 2009; Yacoub, Awwad, Alawi, & Arafat, 2013; Zheng, Wu, & Shao, 2006; Zou, Zhan, Ge, Wei, & Ouyang, 2009).…”

Section: Introductionmentioning

confidence: 99%

Determination of amlodipine, indapamide and perindopril in human plasma by a novel LC–MS/MS method: Application to a bioequivalence study

Rezk

Badr

2020

Biomedical Chromatography

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A robust and rapid UPLC–MS/MS method has been developed, optimized and validated for determination of amlodipine (AML), indapamide (IND) and perindopril (PRN) in human plasma. A positive electrospray ionization mode was used in a Xevo TQD LC–MS/MS instrument. A single sample preparation step using extraction technique was applied to extract the three analytes from plasma samples. There was no need to extract indapamide from blood samples in a further step. Extraction of the three drugs and internal standards was done using a solvent mixture composed of methyl tertiary butyl ether, dichloromethane and ethyl acetate. The prepared samples were analyzed using an Acquity UPLC HSS C18 (100 × 2.1 mm, 1.7 μm) column. Ammonium acetate and methanol, pumped at a flow rate of 0.3 ml/min, were used as a mobile phase. Method validation was done as per the US Food and Drug Administration guidelines. Linearity was achieved in the range of 0.2–15 ng/ml for AML, 0.5–50 ng/ml for IND and 0.5–120 ng/ml for PRN. Accuracy and precision were estimated and found to be within the acceptable ranges. The rapid chromatography permits analysis of many samples per batch, making the method suitable for clinical and pharmacokinetic investigations. The developed and validated method was applied to estimate AML, IND, and PRN in a fasting bioequivalence study in healthy human volunteers.

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Simultaneous quantification of perindopril erbumine, indapamide and amlodipine besylate in newer combination of anti‐hypertensive drugs in pharmaceutical dosage form by thin layer chromatography method

Cited by 7 publications

References 10 publications

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

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

Development and validation of high‐performance thin layer chromatographic method for simultaneous quantitation of novel combination perindopril erbumine and moxonidine hydrochloride

Determination of amlodipine, indapamide and perindopril in human plasma by a novel LC–MS/MS method: Application to a bioequivalence study

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