Establishment of inherent stability on piracetam by UPLC/HPLC and development of a validated stability-indicating method

Sahu, Kapendra; Shaharyar, Mohammad; Siddiqui, Anees A.; Sahu, Shikha

doi:10.1016/j.arabjc.2012.11.003

Cited by 3 publications

(2 citation statements)

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“…For example, when assaying a combination tablet containing diclofenac, paracetamol, and camylofin, the UPLC analysis time was shown to be four times shorter compared to HPLC, and solvent consumption was approximately sixteen times lower [83]. The results of HPLC and UPLC analyses for piracetam were also compared, recording 10 times lower LOD and LOQ values for the same assay in favor of UPLC and a six-times shorter analysis time in isocratic mode [128]. By using UPLC instead of HPLC for the determination of erythropoietin, the total analysis time was reduced from 20 to 4 min while obtaining a greater range of linearity of the method [168].…”

Section: Discussionmentioning

confidence: 99%

UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst

et al. 2022

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In recent years, ultra-efficient liquid chromatography (UPLC) has gained particular popularity due to the possibility of faster separation of small molecules. This technique, used to separate the ingredients present in multi-component mixtures, has found application in many fields, such as chemistry, pharmacy, food, and biochemistry. It is an important tool in both research and production. UPLC created new possibilities for analytical separation without reducing the quality of the obtained results. This technique is therefore a milestone in liquid chromatography. Thanks to the increased resolution, new analytical procedures, in many cases, based on existing methods, are being developed, eliminating the need for re-analysis. Researchers are trying to modify and transfer the analytical conditions from the commonly used HPLC method to UPLC. This topic may be of strategic importance in the analysis of medicinal substances. The information contained in this manuscript indicates the importance of the UPLC technique in drug analysis. The information gathered highlights the importance of selecting the appropriate drug control tools. We focused on drugs commonly used in medicine that belong to various pharmacological groups. Rational prescribing based on clinical pharmacology is essential if the right drug is to be administered to the right patient at the right time. The presented data is to assist the analyst in the field of broadly understood quality control, which is very important, especially for human health and treatment. This manuscript shows that the UPLC technique is now an increasingly used tool for assessing the quality of drugs and determining the identity and content of active substances. It also allows the monitoring of active substances and finished products during their processing and storage.

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Section: Discussionmentioning

confidence: 99%

UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst

et al. 2022

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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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Simple Eco-Friendly RP-LC Method for the Synchronous Separation of Six Widely Used Drugs in the Treatment of Cerebrovascular and Vestibular Disorders: Application for Analysis in Their Single and Combined Drug Products

El-Houssini

Mohammad

2022

Journal of AOAC INTERNATIONAL

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Background RP-LC is considered the most extensively used chromatographic technique in drug separation and quantification; yet its routine use shows increasing environmental challenges about energy consumption, solvent used and waste engendered. From this perception, efforts for Greening the developed RP-LC methods are focused on using of green solvents; reducing the amount of solvent used and waste produced. Objective The target of this work is to develop eco-friendly RP-LC method for the synchronous separation of six widely used drugs in the treatment of cerebrovascular and vestibular disorders namely; neurotropic Piracetam, antihistamines, Dimenhydrinate, Cinnarizine and Fluranizine, vasodilators Vincamine and Vinpocetine. Method Separation and quantification are accomplished at ambient temperature by isocratic elution mode using acetonitrile–0.2% triethylamine (85:15; by volume) as a mobile phase at a flow rate of 1.5 mL/min on Hypersil C18 column. UV detection and quantification are carried out at 225 nm. Results The method is fully validated per ICH guidelines, where all analytical parameters are within acceptable range, r > 0.9999, accuracy ≥99.55% and precision (0.02–0.97%). Conclusion The method is applied for the routine analysis of the cited drugs in their single and combined drug products and it is considered excellent in terms of greenness with respect to Eco-Scale assessment. Highlights As the routine use of RP-LC technique shows increasing environmental challenges, efforts for Greening are attempted focusing on the use of green solvents; reduce the amount of solvent used and waste produced. A simple eco-friendly RP-LC method for the synchronous separation of six widely used drugs in the treatment of cerebrovascular and vestibular disorders is developed. The method is fully validated per ICH guidelines, where all analytical parameter are within acceptable range. -The method is applied for the routine analysis of the cited drugs in their single and combined drug products.

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Establishment of inherent stability on piracetam by UPLC/HPLC and development of a validated stability-indicating method

Cited by 3 publications

References 13 publications

UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst

UPLC Technique in Pharmacy—An Important Tool of the Modern Analyst

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Simple Eco-Friendly RP-LC Method for the Synchronous Separation of Six Widely Used Drugs in the Treatment of Cerebrovascular and Vestibular Disorders: Application for Analysis in Their Single and Combined Drug Products

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