scholarly journals RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Sadana Gangishetty ◽  
Surajpal Verma
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Development And Validation

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5 µm, 250 × 4.6 mm) and a mobile phase containing phosphate buffer (0.05 M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005 M) adjusted to pH 3.2: acetonitrile (50 : 50 v/v) mixture was used for the separation and quantification. The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175 µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation

2021 ◽  
pp. 6061-6065
Author(s):  
Ankita Shinde ◽  
G.B. Gajeli ◽  
Sneha Ubale ◽  
Vinod Matole
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Tablet Formulations ◽  
Hplc Method Development ◽  
Development And Validation

A new, simple, rapid, selective, precise and accurate reverse phase high performance liquid chromatography assay has been developed for simultaneous estimation of Bilastine, and Montelukast in tablet formulations. The separation was achieved by using Phenomenax Kinetex XB C-18 column (150 x 4.6mm, 5 .) using mobile phase Methanol: 0.1% TFA water (80:20). Injection volume was 10µl. The flow rate was 1.0mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 270nm. The retention time of Bilastine and Montelukast was noted to be 1.27, and 4.86 respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.

scholarly journals RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ASPIRIN AND OMEPRAZOLE IN BULK AND DOSAGE FORM

2018 ◽  
Vol 8 (5) ◽  
pp. 322-328
Author(s):  
Tukaram K Sarode ◽  
Prerana B Jadhav
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Water Ph ◽  
Hplc Method Development ◽  
Development And Validation

RP-HPLC method was developed for the determination of Omeprazole (OME) & Aspirin (ASP) in bulk and dosage form. Mobile phase use for the separation of OME & ASP is methanol and 0.05%OPA in water (pH= 3.5) with ratio of 60:40. The Colum used as C18 (Cosmosil) 4.6×150mm and flow rate 0.7mL/min. UV detector is used and the detection wavelength is 231nm. Retention time of OME and ASP are 4.61 & 8.03 min, respectively. This method was validated as per ICH guidelines. Linearity was observed at 10-50µg/mL of OME and 20-100µg/mL of ASP. The % RSD is found to be less than 2%.The resolution between OME and ASP is 11.55 and the tailing factors of both are less than 2.0.Therotical plates for OME and ASP are 5060, and 9367, respectively. Total run time is 15min. The developed RP-HPLC method was accurate, precise, selective and rapid for simultaneous estimation of Omeprazole and Aspirin in the pharmaceutical dosage form.” Keyword: Omeprazole, Aspirin, RP-HPLC validation.

RP-HPLC Method Development and Validation For Simultaneous Estimation of Paracetamol and Mefenamic Acid in Pharmaceutical Suspension

2019 ◽  
Vol 10 (04) ◽  
pp. 583-587
Author(s):  
Venkata Nanda Kumar Kopparapu ◽  
Poornima Kasula ◽  
Ajay Kumar Reddy Ankinapalli ◽  
M Venkateswarlu
Keyword(s):  
Mefenamic Acid ◽  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Inflammatory Conditions ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation

Paracetamol (PCT) and Mefenamic acid (MFA), in combination, is recommended widely for the treatment of antipyretic and anti-inflammatory conditions. The present works carry a new simple, rapid, precise, accurate, and sensitized method of high-performance liquid chromatography with UV detection for simultaneous quantification of PCT and MFA. The samples are eluted in isocratic mode using a Phenomenex ODS 3V C18 (4.6mm × 250 mm i.d, with a particle size of 5μm) with the mobile composition of methanol: phosphate buffer pH 7.1 (70:30) delivered at a flow rate of 1ml/min with the detection wavelength of 254 nm. It shows good linearity response in the concentration range of 15-35 μg/mL and 6-14 μg/ml for PCT and MFA with the retention times of 3.0 min and 4.8 min, respectively. The quantities of PCT and MFA in pharmaceutical suspension were found to be 99.01% and 101.02%, respectively. The method was quantitatively evaluated according to ICH guidelines taking into consideration the required parameters, and the results obtained are within acceptable limits. So, the proposed method can be employed in the routine analysis and evaluation of MFA and PCT in both bulk and suspension dosage form.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

A NOVEL STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (08) ◽  
pp. 54-61
Author(s):  
B. Venkateswara Rao ◽  
◽  
S. Vidyadhara ◽  
V. Basaveswara Rao
Keyword(s):  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Hplc Method Development ◽  
Development And Validation

The prime aim of the present investigation was to develop and validate a novel, precise, accurate, specific, rapid and economical stability- indicating isocratic reverse phase liquid chromatography method for the quantitative simultaneous estimation of valsartan and hydrochlorothiazide in bulk and marketed formulations. Estimation of drugs in this combination was achieved with a C18 column [Kromasil 100-5 C18 column, P134 250 × 4.6 mm] kept at ambient temperature, isocratic mode using mobile phase of composition acetonitrile and phosphate buffer (40:60 V/V, pH 4). The flow rate was 0.8 ml/min and the effluents were monitored at 235 nm, using variable wavelength UV detector. The retention time of valsartan and hydrochlorothiazide were 2.65 min and 3.97 min, respectively. Validation of the method was done according to the ICH guidelines for different analytical parameters. The method was found to be linear over a range of 50-250 μg/mL for valsartan and hydrochlorothiazide. The established method was as reproducible with a %RSD value of less than 2 and having robustness and accuracy within the specified limits. Assay of marketed formulation was determined and was 99.04% and 99.8% respectively. The stressed samples were analyzed. The proposed method was found to be specific and stability indicating as no interfering peaks of degradation compounds and excipients were noticed. The proposed method can be successfully employed in the estimation of commercial formulations.

Sign in / Sign up

Export Citation Format

Share Document