scholarly journals Isolation, Characterization & Phytochemical Screening, Analytical Method Development and Validation for the Determination of Catechins in B.ciliata by RP HPLC Method

2020 ◽  
Vol 13 (2) ◽  
pp. 18-24
Author(s):  
NDVR Saradhi ◽  
N Madan Gopal ◽  
C Madhusudhna Chetty ◽  
K Sushmitha
Keyword(s):  
Method Development ◽  
Analytical Procedure ◽  
Biological Activities ◽  
Research Work ◽  
Hplc Method ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Crude Plant Extract ◽  
Development And Validation

Ayurveda, an ancient system of medicines detailing a number of medicinal plants and their activities in human or animals. The present research work was aimed to develop an analytical procedure for the determination of catechins in the selected plant - B.Ciliata. It is famously known as stone flower/ stone breaker having various biological activities like anti urolithiatic, antiviral, antidiabetic antitumor and cardio protective activity. The methanolic extract of the plant is isolated and a method is developed by using RP HPLC for the determination of catechins in the crude plant extract using a C18 column (200*4.6mm, 5μ) and detected at 241 nm. The method is validated for its system suitability, Linearity, Accuracy, Precision, Robustness and sensitivity as per the ICH guidelines Q2(R1) to meet the analytical procedure in academic and industrial usage

Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

2021 ◽  
pp. 4767-4772
Author(s):  
Krishna Kishore Adireddy ◽  
Srinivasa Rao Baratam ◽  
Nagarjuna Hari Pratap S
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Solution Stability ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC

2021 ◽  
pp. 84-86
Author(s):  
Abhishek Agrawal ◽  
Prem Kumar Bichala ◽  
Swapna Singh
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Laboratory ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.

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 ◽  
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.

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.

Stability Indicating RP-HPLC Method Development and Validation for the Determination of Solifenacin Succinate in Bulk and its Pharmaceutical Formulation

2021 ◽  
pp. 3509-3514
Author(s):  
A. Tanuja ◽  
S. Ganapaty ◽  
Varanasi S N Murthy
Keyword(s):  
Method Development ◽  
Current Method ◽  
Hplc Method ◽  
Pharmaceutical Ingredients ◽  
Solifenacin Succinate ◽  
Ich Guidelines ◽  
Degradation Studies ◽  
Hplc Method Development ◽  
Development And Validation

The current work aims to establish a novel and advanced reverse phase isocratic liquid chromatography system followed by validation and to conduct stability analysis in active pharmaceutical ingredients and formulations for the quantification of Solifenacin Succinate. The optimized elution was achieved with column Sunfire C8 (4.6 x 150mm, 5µm), using the mobile phase of Buffer: Methanol: Acetonitrile in the composition ratio of 45:45:10 v/v. The wavelength of detection was selected as 220nm with 1.0ml/ min flow rate and 30μl injection volume. The retention time of Solifenacin Succinate was found 2.94 min respectively. The method developed has been validated for various analytical parameters according to ICH guidelines. The Linearity was attained at 20 to100 μg/ml of concentration range. The established method was proved as reproducible. The Assay was obtained as 100.40%. The degradation studies were carried out at all degradative conditions and the results of degradation studies denote that the current method was specific, reliable, and economical. Hence, the developed method can be applied for the qualitative and quantitative determination of the selected drug and its commercial formulations.

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.

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