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DEVELEOPMENT AND VALIDATION OFSPECTROFLUOROMETRIC AND SPECTROPHOTOMETRIC BIVARIATE METHODS FOR SIMULTANEOUS DETERMINATION OF PROPRANOLOL AND HYDTOCHLOROTHIAZIDE IN DRUG TABLETS

100%

Wedian F., AbuAlrob R.

Acta Poloniae Pharmaceutica - Drug Research

2020

vol. 77

issue 3

453-463

Spectrofluorometric and spectrophotometric bivariate methods were developed for quantitative of Propranolol and Hydrochlorothiazide in drug tablets in aqueous medium. The methods were tested according to ICH guidelines for linearity, recovery, and specificity and were found accurate, precise, sensitive, and free from interferences. The linearity was established over the ranges 0.025–0.30 and 0.010–0.20 mg/L in the first method, and 1.0–20.0 and 5.0–25.0 mg/L in second method, for PRO and HCT, respectively. The excitation and emission wavelengths were 260, 345 and 270, 415 nm, for PRO and HCT in the first method, respectively. The recoveries were higher than 95% for both methods. Additionally, the results were statistically compared to that of standard chromatographic methods and showed that no significant difference among the methods regarding both accuracy and precision. Thus, the methods were successfully applied to quantitation of PRO and HCT in combined formulations. The proposed methods are reliable, simple, sensitive, and adaptable and could effectively be an alternative method to HPLC.

Impact of hydrochlorothiazide on the stability of two perindopril salts. Evaluation of the interaction with HPLC and ESI LC/MS methods

100%

Juszczak A., Stanisz B. J., Szczołko W., Pieszak M., Cielecka-Piontek J.

Acta Poloniae Pharmaceutica - Drug Research

2018

vol. 75

issue 5

1117-1125

Perindopril (PER) belongs to the group of the angiotensin converting enzyme inhibitors and is widely prescribed antihypertensive drug. It can be used in monotherapy or in combination therapy for example with hydrochlorothiazide (HTH). As on the market there is no pharmaceutical formulation containing both drugs and in literature has not been reported any work about effect of HTH on PER degradation process, the primary objective of this study was the assessment of stability of two salts of perindopril - tert-butylamine (PERt) and arginine (PERa) in a mixtures model with HTH in different relative humidities and constant temperature. Objective of the study was establishing the mechanisms of drug decomposition in the presence of HTH. Results were achieved using the high performance liquid chromatography (RP-HPLC). The degradation rate constants for mixtures and pure substances were calculated. Decomposition products have been analyzed by ESI LC/MS and the decomposition mechanism for each salt has been proposed. The degradation of PERt in the presence of HTH took place according to autocatalytic reaction kinetic mechanism, described mathematically by Prout-Tompkins equation, and the decomposition process leads to hydrolysis. HTH in the model mixture with PERa generates a first-order kinetic model of the decomposition reaction, and there are two main products of decomposition: product of hydrolysis and diketopiperazine. Our study showed that HTH has statistically significant positive impact on both salts. It can be suggested that PERt or PERa and HTH can be formulated together, hence there is no negative interaction between the drugs.

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2 Acta Poloniae Pharmaceutica - Drug Research

1 2020

1 2018

1 AbuAlrob R.

1 Cielecka-Piontek J.

1 Juszczak A.

1 Pieszak M.

1 Stanisz B. J.

1 Szczołko W.

1 Wedian F.

Search results

DEVELEOPMENT AND VALIDATION OFSPECTROFLUOROMETRIC AND SPECTROPHOTOMETRIC BIVARIATE METHODS FOR SIMULTANEOUS DETERMINATION OF PROPRANOLOL AND HYDTOCHLOROTHIAZIDE IN DRUG TABLETS

Impact of hydrochlorothiazide on the stability of two perindopril salts. Evaluation of the interaction with HPLC and ESI LC/MS methods