RP-HPLC Method for Simultaneous Estimation of Vigabatrin, GABA and Taurine in Biological Samples

The present paper describes the development of quick stability indicating RP-HPLC method for the simultaneous estimation of codeine phosphate and chlorpheniramine maleate in the presence of its degradation products, generated from forced degradation studies. The developed method separates codeine phosphate and chlorpheniramine maleate in impurities/degradation products. Codeine phosphate and chlorpheniramine maleate and their combination drug product were exposed to acid, base, oxidation, dry heat, and photolytic stress conditions, and the stressed samples were analysed by proposed method. The proposed HPLC method utilizes the Shimadzu HPLC system on a Phenomenex C18 column (, 5 μ) using a mixture of 1% o-phosphoric acid in water : acetonitrile : methanol (78 : 10 : 12) mobile phase with pH adjusted to 3.0 in an isocratic elution mode at a flow rate of 1 mL/min, at 23°C with a load of 20 μL. The detection was carried out at 254 nm. The retention time of codeine phosphate and chlorpheniramine maleate was found to be around 3.47 min and 9.45 min, respectively. The method has been validated with respect to linearity, robustness, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The developed validated stability indicating HPLC method was found to be simple, accurate, and reproducible for the determination of instability of these drugs in bulk and commercial products.

Download Full-text

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND REPAGLINIDE IN TABLET DOSAGE FORM

Journal of Liquid Chromatography &amp Related Technologies ◽

10.1080/10826076.2011.601492 ◽

2012 ◽

Vol 35 (3) ◽

pp. 385-392 ◽

Cited By ~ 7

Author(s):

Love Kumar Soni ◽

Tamanna Narsinghani ◽

Madhavi Jain

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Metformin Hydrochloride ◽

Simultaneous Estimation ◽

Rp Hplc ◽

Development And Validation ◽

Tablet Dosage

Download Full-text

A simple and sensitive RP-HPLC method for simultaneous estimation of torsemide and spironolactone in combined tablet dosage form

Acta Chromatographica ◽

10.1556/achrom.24.2012.1.2 ◽

2012 ◽

Vol 24 (1) ◽

pp. 15-22 ◽

Cited By ~ 2

Author(s):

P. B. Deshpande ◽

S. V. Gandhi ◽

N. V. Gaikwad ◽

K. S. Khandagle

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

Rp Hplc ◽

Tablet Dosage

Download Full-text

Dronedarone HCl—Quercetin Co-Amorphous System: Characterization and RP—HPLC Method Development for Simultaneous Estimation

Journal of AOAC International ◽

10.1093/jaoacint/qsab024 ◽

2021 ◽

Author(s):

Navya Sree K S ◽

Swapnil J Dengale ◽

Srinivas Mutalik ◽

Krishnamurthy Bhat

Keyword(s):

Method Development ◽

Hplc Method ◽

Molar Ratio ◽

Simultaneous Estimation ◽

Content Uniformity ◽

Amorphous System ◽

Simultaneous Quantification ◽

Linearity Range ◽

Rp Hplc ◽

Economic Method

Abstract Background Dronedarone HCl is an anti-arrhythmic drug indicated for atrial fibrillation. Dronedarone HCl(DRN) has a low solubility of 2 µg/mL and 4% bioavailability, thus it is formulated as co-amorphous system to enhance its solubility by using Quercetin(QCT) as coformer. Literature lacks a sensitive, accurate and economic method for simultaneous quantification of DRN and QCT in formulation. Objective To develop a RP-HPLC method for simultaneous estimation of DRN and QCT in DRN-QCT co-amorphous system. Method Co-amorphous system was prepared using solvent evaporation technique using DRN and QCT in 1:1 molar ratio. The separation was achieved on Purospher® STAR C18 (250 mm × 4.6 mm × 5 μm) column with mobile phase comprising of Acetonitrile and 25 mM phosphate buffer pH 3.6 (60:40, % v/v). Results DRN and QCT retained at 6.7 and 3.5 min, respectively. For both molecules, method was developed with a wide linearity range of 0.2–500 µg/mL. LOD for DRN was found to be 0.0013 and 0.0026 µg/mL for QCT. Also, LOQ for DRN was found to be 0.0041 and 0.0078 µg/mL for QCT. Conclusion Method was validated as per ICHQ2R1 guidelines for linearity, precision, accuracy, and robustness. The method was used in simultaneous quantification of DRN and QCT in co-amorphous samples. Highlights The method developed was used for the analysis of content uniformity and solubility samples of co-amorphous system, where the method was able to successfully quantify DRN and QCT. Low detection and quantification limits contribute to sensitivity of the method and wide linearity range assures the robust and precise quantification of molecules.

Download Full-text

SIMULTANEOUS ESTIMATION OF CURCUMIN AND GEFITINIB IN BULK AND TISSUE SAMPLES (PLASMA AND BRAIN HOMOGENATE) BY RP-HPLC: APPLICATION TO A DISTRIBUTION STUDY

INDIAN DRUGS ◽

10.53879/id.56.07.11330 ◽

2019 ◽

Vol 56 (07) ◽

pp. 59-68

Author(s):

H Mahajan ◽

S Savale ◽

P Nerkar ◽

Keyword(s):

Flow Rate ◽

Mobile Phase ◽

Internal Standard ◽

Brain Homogenate ◽

Reversed Phase ◽

Hplc Method ◽

Simultaneous Estimation ◽

Bulk Analysis ◽

Experimental Conditions ◽

Rp Hplc

The present study was aimed at developing a Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) method for simultaneous determination of curcumin (CRM) and gefitinib (GFT) in bulk, plasma and brain homogenate. hydrochlorothiazide was used as an internal standard (IS). A new simple, rapid, selective, precise and accurate RP-HPLC method has been developed. The separation was achieved by using C-18 column (Qualisil BDS C18, 250 mm x 4.6 mm I.D.) coupled with a guard column of silica, mobile phase consisted of acetonitrile: water with 0.1% formic acid (30:70 v/v). The flow rate was 0.2 ml/min and the drug was detected using PDA detector at the wavelength of 242 nm. The experimental conditions, including the diluting solvent, mobile phase composition, column saturation and flow rate, were optimised to provide high-resolution and reproducible peaks. The method was developed and tested for linearity range of 10-60 μg/mL for bulk analysis and 200-800 ng/mL for plasma and brain homogenate. The developed method was validated as per ICH guidelines, in terms of linearity, application of the proposed method to bulk sample, recovery, precision, repeatability, ruggedness, sensitivity (LOD and LOQ) and robustness and stability study (short and long-term stabilities, freeze/thaw stability, post-preparative). The low value of % RSD showed that the method was precise within the acceptance limit of 2%. The developed method was successfully applied for the analysis of the drug in bulk as well as various marketed formulation and drug in plasma and brain distribution studies.

Download Full-text

DEVELOPMENT, VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TENOFOVIR DISPROXIL FUMARATE, EMTRICITABINE AND RILPIVIRINE HYDROCHLORIDE IN BULK, FORMULATION AND USED IN NANOSUSPENSION

INDIAN DRUGS ◽

10.53879/id.56.09.11663 ◽

2019 ◽

Vol 56 (09) ◽

pp. 43-54

Author(s):

K Vijaya Sri ◽

M. Madhuri ◽

V. Anusha ◽

V.R.K. Siresha ◽

Keyword(s):

Research Work ◽

Multicomponent System ◽

Hplc Method ◽

Combination Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Line Of Therapy ◽

Development And Validation

The present research work illustrates the development and validation of RP HPLC method for simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride in bulk and formulated in a pharmaceutical dosage form as a nanosupension. Antiretroviral drug treatment is the primary line of therapy for treating HIV. The multicomponent system formulated as a nanosuspension evidenced increased hydrophilicity, potency and decreased side effects. The separation was carried out by using efficient BDS hypersil C18 HPLC column with empower software. Combination method of Precipitation—ultrasonic homogenization was used for the preparation of the nanosuspension. The mobile phase used was methanol, water, acetonitrile (80:13.4:6.6) v/v and flow rate 1mL /min. The developed method was thus validated as per ICH guidelines for various parameters whose results advocated the reliability of the method. The results for parameters viz. retention times of tenofovir disproxil fumarate, emtricitabine and rilpivirine were 3.09 min, 2.78 min and 3.68 min, linearity range was between 7.5-90, 5-60, 0.625-7.5µg/mL, respectively. Thus the new RP-HPLC method is optimum, reliable and can be used for the simultaneous estimation of tenofovir disproxil fumarate, emtricitabine and rilpivirine hydrochloride.

Download Full-text