High performance liquid chromatography for simultaneous determination of xipamide, triamterene and hydrochlorothiazide in bulk drug samples and dosage forms

El-Hay, Soad S. Abd; Hashem, Hisham; Gouda, Ayman A.

doi:10.1515/acph-2016-0022

Cited by 23 publications

(17 citation statements)

References 23 publications

(31 reference statements)

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“…Green color symbolizes low ecological impact, while yellow and red colors represent higher impacts. GAPI was used to compare the proposed method to the other reported methods [18,19] ( Fig. 3).…”

Section: Evaluation Of the Analytical Proceduresmentioning

confidence: 99%

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An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

Ayad

Hosny

Ibrahim

et al. 2020

AChrom

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Abstract In the last few years, the use of surfactants as mobile phase additives in reversed phase liquid chromatography (RPLC) has been steadily developing and improving. Surfactants modify the polarity of the stationary phase which in turn decreases the amount of organic solvent required for elution of the analytes rendering the methodologies linked to them greener and more eco-friendly. Brij-35 is a fatty alcohol ethoxylates non ionic surfactant, which is less widely used as mobile phase additive. Brij-35 can decrease stationary phase polarity while remaining neutral. In this research, Brij-35 was studied in the separation and determination of marketed antihypertensive combination therapy composed of triamterene (TRM) and xipamide (XIP). TRM and XIP are diuretics used for treatment of essential hypertension and associated edema conditions. Chromatographic separation was achieved on RP-C18 column (Kinetix®, 5 µm, 15 cm × 4.6 mm) at flow rate 1 mL min−1 and UV-detection at 254 nm. Isocratic elution was performed using mobile phase composed of 0.1 M Brij-35: methanol (MeOH) (60:40, v/v). The analytes were well separated and quantified within linearity ranges of 5–50 µg mL−1 for both drugs in short retention time (2.6 and 5.3 min. for TRM and XIP, respectively). Since claiming greenness is not enough, Green Analytical Procedure Index (GAPI) was used to demonstrate the superiority of the proposed method over the previously reported methods. GAPI is a new metric for evaluation of the ecological impact of analytical procedures. The proposed method was validated according to ICH guidelines and applied successfully for simultaneous determination of the drugs in their co-formulated tablets.

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Section: Evaluation Of the Analytical Proceduresmentioning

confidence: 99%

“…So, the elution time of our drugs under study was quite longer. Only three methods were reported focusing on determination of the drugs under study using HPLC-UV detection [17][18][19]. Two of those methods have the disadvantage of using gradient technique with run time exceeding 12 min.…”

Section: Introductionmentioning

confidence: 99%

An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

Ayad

Hosny

Ibrahim

et al. 2020

AChrom

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“…It has a relatively inefficient effect for treatment of antihypertensive when used alone; so it is used in combination with a potent diuretic (e.g. anthranilic acid or thiazide derivative) to give a synergistic action [8]. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide is a thiazide class diuretic.…”

Section: Introductionmentioning

confidence: 99%

“…The literature review shows that triamterene and hydrochlorothiazide were determined in their bulk powder by derivative ratio spectrophotometry [10] and liquid chromatography [8]. The aim of this work is to develop and validate a new analytical method for determination of the tertiary mixture triamterene and hydrochlorothiazide in presence of impurity of hydrochlorothiazide (chlorothiazide) as well as determination of spironolactone and furosemide in presence of impurity of furosemide (anthranilic acid) in bulk powder and pharmaceutical dosage form without interference or prior separation.…”

Section: Introductionmentioning

confidence: 99%

Determination of antihypertensive drugs by using ratio difference spectrophotometric method

et al. 2019

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An accurate, sensitive and time saving spectrophotometric method has been developed and validated for the determination of two antihypertensive drug mixtures. Mixture 1 contains spironolactone (SPIR), furosemide (FUR) and anthranilic acid (ANTH) (impurity of furosemide) and mixture 2 contains triamterene (TRI), hydrochlorothiazide (HCZ) and chlorothiazide (CZ) (impurity of hydrochlorothiazide). In mixture 1, the determination of drugs depends on dividing the spectrum of ternary mixture by the spectrum of 10 µg/mL of standard furosemide and then spironolactone and anthranilic acid were determined using the difference in amplitude between 242.3 and 254.6 nm, and between 250.8 and 242.4 nm in the ratio spectrum, respectively. On the other hand, furosemide could be determined by dividing the spectrum of ternary mixture by the spectrum of 10 µg/mL of standard spironolactone and then it was determined using the difference in amplitude between 244.8 and 229.7 nm in the ratio spectrum. In mixture 2, the determination of drugs depends on dividing the spectrum of ternary mixture by spectrum of 10 µg/mL of standard triamterene and then hydrochlorothiazide and chlorothiazide were determined using the difference in amplitude between 268.9 and 232.8 nm, and between 292.9 and 250.7 nm in the ratio spectrum, respectively. On the other hand, triamterene could be determined by dividing spectrum of ternary mixture by spectrum of 10 µg/mL of standard hydrochlorothiazide and then triamterene was determined using the difference in amplitude between 230.1 and 244 nm in the ratio spectrum. The developed analytical methods were validated regarding good accuracy and precision according to The International Conference on Harmonisation guidelines, and they were applied to pharmaceutical preparations in addition to laboratory prepared mixtures successfully. Statistically the results were compared with those obtained by reported method and no significant difference was found.

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“…Reviewing the literature revealed that many analytical methods have been developed for the assay of XIP including: spectrophotometry, spectrofluorimetry, high‐performance liquid chromatography (HPLC), thin‐layer chromatography–densitometry and electrochemical methods…”

Section: Introductionmentioning

confidence: 99%

Two liquid chromatographic approaches for the simultaneous determination of xipamide and its degradation product (2,6‐xylidine) using time‐programmed fluorescence detection

Tolba

Belal

2016

Luminescence

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A study of the performance of reversed-phase chromatography with a programmable multiwavelength fluorimetric technique using either conventional hydro-organic or micellar eluent is established for the determination of xipamide (XIP) in the presence of its degradation product, 2,6-xylidine (XY). In conventional liquid chromatography (CLC), the analyses were carried out on a Promosil ODS 100 Å column (250 mm × 4.6 mm i.d., 5 μm) using a mobile phase consisting of methanol/0.1 M phosphate buffer (65: 35, v/v) at pH 4.0. For micellar liquid chromatography (MLC), a short Spherisorb column (150 mm × 4.6 mm i.d., 5 μm) was employed in conjunction with a greener mobile phase (pH 5.0) containing 0.1 M sodium dodecyl sulfate and 15% n-propanol. CLC proved to be superior to MLC in terms of sensitivity for the determination of the degradation product because it could detect trace amounts down to 10.0 ng/ml of XY as a degradation product in XIP. However, MLC represents an eco-friendly approach for the simultaneous determination of XIP and XY. In addition, the opportunity for the direct introduction of biological matrices into the chromatographic system is one of the distinctive benefits of MLC. The proposed methods were applied for the determination of XIP in its tablets, human urine and content uniformity testing. The results of the proposed methods were statistically compared with those obtained using the comparison fluorimetric method, revealing no significant differences in the performance of the methods regarding accuracy and precision.

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High performance liquid chromatography for simultaneous determination of xipamide, triamterene and hydrochlorothiazide in bulk drug samples and dosage forms

Cited by 23 publications

References 23 publications

An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

An eco-friendly micellar HPLC method for the simultaneous determination of triamterene and xipamide in active pharmaceutical ingredients and marketed tablet dosage form

Determination of antihypertensive drugs by using ratio difference spectrophotometric method

Two liquid chromatographic approaches for the simultaneous determination of xipamide and its degradation product (2,6‐xylidine) using time‐programmed fluorescence detection

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