A validated stability-indicating HPLC method for simultaneous determination of Silymarin and Curcumin in various dosage forms

Korany, Mohamed A.; Haggag, Rim S.; Ragab, Marwa A.A.; Elmallah, Osama A.

doi:10.1016/j.arabjc.2013.06.021

Cited by 51 publications

(22 citation statements)

References 20 publications

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“…HPTLC has higher sensitivity than TLC but less sensitive than HPLC. [32][33][34][35][36][37][38][39][40][41][42] Rufinamide, Roflimilast, Pragabalin, Nizatidine, Naftopidil, Dexamethasone and Moxifloxacin, Levocabastine, AMLO-VAL-HCTZ, Eremantholide C, Silymerin and curcumin, Sofosbuvir and Ledipasvir, n-acetyl cysteine, HPLC -DAD SIM [43][44][45][46][47][48][49][50][51][52][53][54] Diclofenac, Piracetam, Rivaroxaban, Ofloxacine & ornidazole UPLC SIM [55][56][57][58] Isoflavone aglycone in soybean UFLC SIM 59 Desonide HPTLC SIM 60 Loratadine, Clobetasol, TLC SIM [61][62] Nicardipine, Azilsartan medoxomil Pottasium, HPLC-MS SIM [63][64] Ezetimibe, Simavastatin, Zidovudine HPLC-MS/MS SIM [65][66][67] HPTLC has advantages over large no of the sample can apply on a single plate, and the amount of mobile phase required is small, so it has costeffective analysis. HPLC UV method is the most commonly used method for development of stability indicating method, but it has a limit of its detection ability; however it is more sensitive than TLC and HPTLC method.…”

Section: Analytical Instrument Used In Stability Indicating Methods Dementioning

confidence: 99%

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2019

IJPSR

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Stability of pharmaceuticals is defined as the ability to retain the quality, purity, Identity, and safety throughout the shelf life of products. It is of main concern because drug substance and products lose its Potency and quality after the time passes, due to change in environmental conditions such as temperature, light, and humidity. It is essential that quality of drugs should maintain throw out the life cycle of drug products for their safe and effective use. The need for constant monitoring of the drug substance and product for their quality and purity has the origin of the development of various stability testing methods. Stability testing now becomes a regulatory requirement for filing NDA and ANDA to USFDA and various regulatory agencies. Stability indicating methods had originated from advancement in various analytical instrument technologies. Stability indicating methods of drug substance and products have the ability for separation, identification, qualification, and quantification of all impurities associated with drug substance and drug product at any storage Conditions to give the exact concentration of drug substance or analyte at any time point over the shelf life of products and beyond. These are helpful to understand the degradation pathways as well as obtaining knowledge about impurities developed during processing which should not be present in drug products or have a specific limit, if present. The present review explored the importance, regulatory requirement, various analytical techniques used and some successfully developed stability indicating methods for different drug substance and drug products. INTRODUCTION: Drug substance is defined as an active ingredient which is used in the treatment and mitigation of various diseases and disorders whereas, drug products are defined as the different marketed formulations present for drug substance to take or easily administered in the patient for showing its required therapeutic effect.

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Section: Analytical Instrument Used In Stability Indicating Methods Dementioning

confidence: 99%

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2019

IJPSR

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“…Safety of curcumin at very high doses has been proved in various animal and human studies. These studies led to the approval of curcumin as a 'generally regarded as safe (GRAS)' ingredient by the food and drug administration (FDA) of the United States of America, by the natural health products directorate of Canada and the expert joint committee [6].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Rp-HPLC Method for Simultaneous Estimation of Curcumin and Piperine

Khismatrao

Bhairy²,

Hirlekar

2018

Int J App Pharm

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Objective: The present study was aimed to develop a simple, sensitive and precise high performance liquid chromatographic (HPLC) method for the simultaneous estimation of curcumin and piperine and to implement the developed method for the estimation of curcumin and piperine in the nanoparticulate formulation.Methods: Method development was performed using various solvent, buffer-solvent ratios, at different flow rates for adequate separation of both drugs. The developed method was validated in accordance with the international conference on harmonization (ICH) guidelines. The developed method was implemented to estimate the amount of curcumin and piperine in the nanoparticulate formulation.Results: Chromatographical conditions were optimized, and the best chromatographical conditions with adequate resolution for curcumin and piperine was achieved using enable C18G reverse phase column, using a mobile phase combination of acetonitrile and phosphate buffer (pH 3)in a ratio of 70:30 v/v at a flow rate of 1.0 ml/min. The detection was monitored at a wavelength of 360 nm. The retention time of curcumin and piperine was found to be 7.2 min and 8.5 min respectively. Conclusion:The developed analytical method is simple, precise, and reproducible and thus can be used for simultaneous estimation of curcumin and piperine in pharmaceutical formulations.

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“…HPLC-PDA methods were also reported for determination of curcumin [12] and simultaneous estimation of piperine and curcumin in nanoparticulate formulation [13]. A stability-indicating HPLC method for quantitative determination of curcumin in laboratory samples [14] and simultaneous estimation of silymarin and curcumin also have been reported [1]. Several other methods such as fluorimetric methods [15] and NMR methods [16] have been used for the determination and rapid quantitation of curcumin.…”

Section: Fig 1: Chemical Structure Of Curcuminmentioning

confidence: 99%

“…1). Mostly, it is available in the market as a mixture of three different constituents, commonly known as curcuminoids [1,2,3]. It is a coloring principle in turmeric and has been found to have a wide range of pharmacological activities and exhibits significant therapeutic potential in the treatment of wound healing [4], cancer [5], arthritis, atherosclerosis, diabetes mellitus, fever, gastric ulcer, inflammatory bowel disease, lung diseases, malaria, multiple sclerosis, myocardial infarction, osteoporosis, pancreatitis, psoriasis [6].…”

Section: Introductionmentioning

confidence: 99%

A New Stability-Indicating Rp-HPLC Method for Determination of Curcumin: An Application to Nanoparticulate Formulation

Panigrahi

Hirlekar

2016

Int J Pharm Pharm Sci

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Objective: The present study was aimed to develop a rapid, accurate, linear, sensitive and stability-indicating high performance liquid chromatographic method for determination of curcumin and to implement the developed method for the estimation of curcumin in the nanoparticulate formulation. Methods:Method development was performed using various solvent, buffer-solvent ratios, at different flow rates for better resolution and to decrease the run time. The developed method was validated in accordance with the international conference on harmonization (ICH) guidelines. The developed method was implemented to estimate the amount of curcumin in the curcumin-nanoparticulate formulation. Results:The optimum chromatographic conditions with adequate resolution for curcumin (16.10 min) was achieved when the separation was carried using C18 Conclusion:The developed analytical method is simple, precise, and reproducible and thus can be used for stability-indicating analysis of curcumin in pharmaceutical formulations. column at ambient temperature with an isocratic elution mode of mobile phase composed of a degassed mixture of phosphate buffer pH 3 and acetonitrile (50:50 v/v) at 1.0 ml/min flow rate with a total run time of 20 min. The developed method was validated for system suitability, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), linearity and range. The LOD and LOQ were found to be 0.018 and 0.056 μg/ml respectively, which indicates that the method was sensitive, and can detect and quantify at lower levels of curcumin. Linearity range was from 5-15 μg/ml for curcumin with regression coefficient 0.997 indicates that at this concentration range curcumin was highly linear. Percent assay of curcumin was found to be 98.7% and curcumin recovered was found to be 0.78 mg which are estimated by using the developed method.

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A validated stability-indicating HPLC method for simultaneous determination of Silymarin and Curcumin in various dosage forms

Cited by 51 publications

References 20 publications

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Development and Validation of Rp-HPLC Method for Simultaneous Estimation of Curcumin and Piperine

A New Stability-Indicating Rp-HPLC Method for Determination of Curcumin: An Application to Nanoparticulate Formulation

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