scholarly journals Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC

2014 ◽  
Vol 2014 ◽  
pp. 1-5
Author(s):  
Rihana Parveen Shaik ◽  
Srinivasa Babu Puttagunta ◽  
Chandrasekar Kothapalli Bannoth ◽  
Bala Sekhara Reddy Challa
Keyword(s):  
Method Development ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Ich Guidelines ◽  
Phase Combination ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A new, accurate, precise, and robust HPLC method was developed and validated for the determination of solifenacin in tablet dosage form. The chromatographic separation was achieved on an Inertsil ODS 3V C18 (150 mm × 4.6 mm, 5 μm) stationary phase maintained at ambient temperature with a mobile phase combination of monobasic potassium phosphate (pH 3.5) containing 0.1% triethylamine and methanol (gradient mode) at a flow rate of 1.5 mL/min, and the detection was carried out by using UV detector at 220 nm. The performance of the method was validated according to the present ICH guidelines.

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.

METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PIOGLITAZONE IN BULK SAMPLES AS WELL AS IN TABLET DOSAGE FORMS BY USING RP -HPL C

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (09) ◽  
pp. 42-46
Author(s):  
M Debnath ◽  
◽  
A. S. Kumar ◽  
V. D. S Ganta
Keyword(s):  
Method Development ◽  
Dosage Forms ◽  
Hplc Method ◽  
Uv Detector ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
The Mean ◽  
Development And Validation ◽  
Tablet Dosage

A simple and precise RP‐HPLC method was developed and validated for the determination of pioglitazone hydrochloride in pharmaceutical dosage forms. Chromatography was carried out using Kromosil- C18 ODS column (250 x 4.6 mm; 5 μm), mixture of acetate buffer: methanol (40:60 v/v) as the mobile phase at a flow rate 1.0 mL/min. The analyte was monitored using UV detector at 254 nm. The retention time for pioglitazone HCl was 3.063 min. The proposed method was found linear in the concentration range of 20.0‐70.0 μg/ml with correlation coefficient of r2=0.9999. The developed method has been statistically validated and found simple and accurate. The mean recoveries obtained for pioglitazone HCl were in the range 99.20-101.59%. Due to its simplicity, rapidness, high precision and accuracy of the proposed method it may be used for determining pioglitazone HCl in bulk and dosage forms.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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.

scholarly journals Method development and validation of droxidopa by HPLC technique

2020 ◽  
Vol 11 (4) ◽  
pp. 6227-6232
Author(s):  
Bharani Pandilla ◽  
Chitra K ◽  
Nalini C N ◽  
Ashok P
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Precise Determination ◽  
Graphic System ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Technique ◽  
Development And Validation

The purpose of this work is to develop and validate stability, indicating reverse phase High-performance liquid chromatography (HPLC) method for the rapid and precise determination of droxidopa in its pure form and formulations. A simple, fast, accurate and economical way has been developed and validated for the quantification of droxidopa by HPLC technique. The chromato graphic system was equipped with Shimpack columnC18((250x 4.6) mm, 5µ) as stationary phase and UV detector at 220 nm, in conjunction with a mobile phase of phosphate buffer pH 2.0:acetonitrile (60:40,% v/v) at a flow rate of 1.0 mL/min. The developed HPLC technique was found to be rapid as the retention time was 2.2 minutes for droxidopa peak to elute. The method was validated as per the International Conference on Harmonization (ICH) guidelines for specificity linearity, accuracy, precision. The developed method was selective with well-resolved peak. Linearity was observed over the concentration range of 25-150µg/mL for droxidopa. The recovery of Droxidopa was found to be 100.54% - 101.65%. Statistical techniques were employed for the validation of precision, linearity, accuracy, robustness and ruggedness and can be applied for routine analysis. Validation revealed that the developed method was specific, accurate, precise, reliable, robust, reproducible and suitable for the systematic quantitative review.

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.

Method Development and Validation of Canagliflozin by using RP-HPLC in Pure and Tablet Dosage Form

2021 ◽  
pp. 209-212
Author(s):  
Swapna Singh ◽  
Prem Kumar Bichala ◽  
Abhishek Agrawal
Keyword(s):  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Intermediate Precision ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Column Flow Rate

A new method was established for simultaneous estimation of Canagliflozin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Canagliflozin by using INERTSIL column, C18 (150x4.6)5µm column, flow rate was 1ml/min, mobile phase ratio was Water: Acetonitrile (70:30), detection wavelength was 264nm. The instrument used was Hitachi HPLC Auto Sampler, Separation module 1575. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for Canagliflozin was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, %mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, %RSD for intermediate precision was 0.5 and 0.1 respectively.

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.

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