A Prospective Validation of Hydrocholorothiazide and Bisoprolol Fumerate in its Pure and Bulk Dosage Forms by using RP-HPLC Technique

Beula, S. Janet; Suthakaran, R.; Bichala, Prem Kumar; Shankar, Ch.; Ghouse, Syed; Suneetha, K.

doi:10.5958/2231-5675.2020.00001.0

Cited by 4 publications

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“…The present study envisages developing and validating the Q-absorbance UV-spectrophotometric method for simultaneously estimating BF and CLD in their tablet formulation. Determination of BF alone and in combinations with other drugs is reported in the literature by various methods, that is, UV Spectrophotometry, [6][7][8][9] HPTLC, [10][11][12] HPLC, [13][14][15][16][17][18][19] and capillary electrophoresis. [20][21][22] Furthermore, determination of CLD alone or with other drugs by HPTLC, [23][24][25][26][27][28] HPLC, [29][30][31][32][33][34] and spectrophotometry [30,[35][36][37][38][39][40][41][42][43][44][45] is reported.…”

Section: Original Articlementioning

confidence: 99%

Untitled

2022

AJP

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Introduction: Cardiovascular disorders involve simultaneous administration of more than one drug; hence, numerous combinations, including calcium channel blockers and beta-blockers, are available in the market and are approved by various regulating authorities. Cilnidipine (CLD), a calcium-channel blocker, and Bisoprolol fumarate, a β1-adrenergic receptor blocking agent are such combinations available on the market. This combination is used in the treatment of hypertension and angina pectoris. Therefore, these drugs must be accurately analyzed in various samples, including laboratory mixtures and marketed formulations. Methods: Simultaneous estimation of Bisoprolol fumarate and CLD in marketed formulation Basicore C5 was carried out using the UV spectrophotometric method in ethanol. The Q-Absorbance ratio method was selected for estimation. The wavelengths used were 224.5 nm, λmax of Bisoprolol fumarate, and 232 nm, an iso-absorptive point of both the drugs. Results: Beer's law was obeyed in the concentration range between 2 and 10 μg/mL for both the drugs. Recovery studies have validated the analysis results as per ICH guidelines. Accuracy was found between 99.3-99.75% and 99.48-100.06% for Bisoprolol fumarate and CLD, respectively. The limit of detection was 0.0943 and 0.0751 μg/mL for Bisoprolol fumarate, while 0.0355 and 0.1141 μg/mL for CLD at 224.5 and 232 nm, respectively. The limit of quantifications was 0.2860 and 0.8983 μg/mL for Bisoprolol fumarate, while 0.1610 and 0.3457 μg/mL for CLD at 224.5 and 232 nm, respectively. Conclusion: The method was simple, reproducible, rapid, and precise. Hence, it could analyze laboratory samples and marketed formulations containing these two drugs.

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Section: Original Articlementioning

confidence: 99%

Untitled

2022

AJP

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An Internal Standard High-Performance Liquid Chromatography Method for Simultaneous Quantification of Candesartan and Hydrochlorothiazide in Combined Formulations

Algethami

2021

Orient. J. Chem

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The internal standard method is a versatile procedure that avoids misleading results caused by the instability of the chromatographic system or inexperienced workers. It is an effective way to judge the accuracy of any obtained data. As the detector responses of chlorzoxazone (CZN) resemble those of candesartan (CDZN) and hydrochlorothiazide (HCTZ), CZN was employed as an internal standard. Herein, a simple chromatographic method was established for quantification of CDZN and HCTZ. Isocratic elution was conducted using 1% premixed acetonitrile/formic acid (7:3 v/v) at a 0.8 mL/min flowrate. The separation of the three components was maintained using the universal 20 µL loop, and for further simplicity in application, the analysis was optimized at 25 °C. CDZN, HCTZ, and CZN were simultaneously monitored and quantified at 270 nm. The method developed here complies with all the validation limits according to the British Pharmacopoeia (BP), United States Pharmacopoeia (USP), and the guidelines of the International Council ForHarmonisation (ICH). The method proved to be linear in the range of 6.4 to 25.6 µg/mL and 5.0–20 µg/mL for CDZN and HCTZ, respectively, while the quantitation detection limits were less than 1.0µg/mL for both.

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Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

Sharma¹,

Ankalgi²,

Devi³

et al. 2021

AJPA

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A rapid isocratic chromatographic procedure for the analysis of methotrexate, hydroxychloroquine sulfate in bulk drug and pharmaceutical formulations was developed validated in the present study. The mobile phase consists of a mixture of Water: Acetonitrile: Tetrahydrofuran in the proportion of 50:40:10 and pH maintained to 3with perchloric acid. Retention time was found to be 3.0 and 3.7minutes for methotrexate and hydroxychloroquine sulfate respectively. The method was performing by using the C18 column, ODS Hypersil column with UV detection at 318nm, and flow rate of 1.0ml/min. The percentage of recovery for both drugs was found to be 99.99%. All validation parameters were within limits as per the ICH guidelines.

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A Prospective Validation of Hydrocholorothiazide and Bisoprolol Fumerate in its Pure and Bulk Dosage Forms by using RP-HPLC Technique

Cited by 4 publications

References 0 publications

Untitled

Untitled

An Internal Standard High-Performance Liquid Chromatography Method for Simultaneous Quantification of Candesartan and Hydrochlorothiazide in Combined Formulations

Analytical Method Development and Validation for Simultaneous estimation of Methotrexate and Hydroxychloroquine sulfate in bulk drug by using RP-HPLC

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