A New Analytical HPLC Method for Quantification of Mometasone Furoate, Nadifloxacin and Miconazole Nitrate in Semisolid Dosage Form

Abstract Nadifloxacin, mometasone furoate and miconazole nitrate are formulated together as a topical antifungal dosage form. In this work, a reversed-phase ultra-performance liquid chromatographic method coupled with a diode array detector (RP-UPLC-DAD) was developed and validated to determine nadifloxacin, mometasone furoate and miconazole nitrate simultaneously in their bulk powder, in pharmaceutical preparation and in spiked human plasma samples. Separation was achieved on an ACQUITY UPLC C18 column of 2.2 μm particle size (2.1 × 100 mm) via isocratic elution using a mobile phase consisting of methanol, acetonitrile and water with ratio (50:20:30; v/v/v) and 0.1 g ammonium acetate, then pH was adjusted to (7.00) using acetic acid, flow rate 0.6 mL/min, temperature 30°C and UV detection at 220 nm. The method is linear in a range from 5 to 400 μg/mL for both nadifloxacin and miconazole nitrate and from 20 to 500 μg/mL for mometasone furoate. The method was validated according to the ICH guidelines then applied successfully to determine the mentioned drugs in their pharmaceutical preparation and spiked human plasma samples. For plasma samples, the results showed that the method can determine nadifloxacin, mometasone furoate and miconazole nitrate in human plasma samples with high accuracy and precision.

Download Full-text

Application of RP-HPLC method for stability study and quantifying decitabine in bulk drug and in pharmaceutical dosage form

International Journal of Pharmaceutical Research ◽

10.31838/ijpr/2020.12.04.064 ◽

2020 ◽

Vol 12 (04) ◽

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Stability Study ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Bulk Drug

Download Full-text

Simultaneous Estimation of Ilaprazole and Domperidone in Pharmaceutical Dosage Form

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2016.9.6.6 ◽

2016 ◽

Vol 9 (6) ◽

pp. 3549-3555

Author(s):

Gopi Patel ◽

Kiral M Prajapati ◽

Bhavesh Prajapati ◽

Samir K Shah

Keyword(s):

Dosage Form ◽

Ammonia Solution ◽

Hplc Method ◽

Simultaneous Estimation ◽

Control Analysis ◽

Linear Calibration ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Water Ph ◽

Alkali Hydrolysis

A simple, accurate and precise stability-indicating RP-HPLC method was developed and subsequently validated for simultaneous determination of ilaprazole and domperidone in bulk and pharmaceutical dosage form. The proposed HPLC method utilizes C18 (250 mm × 4.6 mm × 5 µm) column with mobile phase comprising of 0.5 % glacial acetic acid in water pH 5.5 adjusted with ammonia solution: methanol in the ratio 45:55 v/v at a flow rate of 1.0 ml/min. Quantitation was achieved with UV detection at 286 nm based on peak area with linear calibration curves at concentration ranges 80-120µg/ml for ilaprazole and 240-360 µg/ml for domperidone with correlation coefficient of 0.999.The retention times of ilaprazole and domperidone were found to be 3.0 min, 5.4 min respectively. The mean recoveries obtained for ilaprazole and domperidone were found to be 99.76 ± 0.6463 % and 100.7 ± 0.2424 % respectively. Stress testing which covered acid, alkali hydrolysis, and peroxide, photolytic, thermal degradation was performed to prove the specificity of the proposed method and degradation was achieved. The proposed method was successfully applied for the stability indicating simultaneous estimation of ilaprazole and domperidone in routine quality control analysis in bulk and pharmaceutical formulation.

Download Full-text

Development and validation of RP-HPLC method for simultaneous estimation of teneliglipt in hydro bromide hydrate and glimepiride in bulk and tablet dosage form

International Journal of Pharma and Bio Sciences ◽

10.22376/ijpbs.2019.10.2.p18-25 ◽

2019 ◽

Vol 10 (2) ◽

Author(s):

I.PONN ILAVARASAN ◽

TAMILSELVI N ◽

ABINAYA N ◽

GAYATHRI R

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Simultaneous Estimation ◽

Rp Hplc ◽

Development And Validation ◽

Tablet Dosage

Download Full-text

A A RAPID AND SENSITIVE RP-HPLC METHOD FOR THE QUANTITATIVE ANALYSIS OF EMPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2019v11i5.33281 ◽

2019 ◽

pp. 60-65

Author(s):

MADHURIMA BASAK ◽

Santhosh Reddy Gouru ◽

Animesh Bera ◽

Krishna veni Nagappan

Keyword(s):

Quantitative Analysis ◽

High Performance ◽

Dosage Form ◽

Limit Of Detection ◽

Hplc Method ◽

Reverse Phase ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Limit Of Quantitation ◽

Bulk Drug

Objective: The present study aims at developing an accurate precise, rapid and sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for assessing Empagliflozin in bulk drug and in the pharmaceutical dosage form. Methods: The proposed method employs a Reverse Phase Shim Pack C18 column (250 mm × 4.6 mm id; 5 µm) using a mobile phase comprising of acetonitrile and water in the ratio of 60:40 v/v flushed at a flow rate of 1 ml/min. The eluents were monitored at 223 nm. Results: Empagliflozin was eluted at a retention time of 5.417 min and established a co-relation co-efficient (R2>0.999) over a concentration ranging from 0.0495-100µg/ml. Percentage recovery was obtained between 98-102% which indicated that the method is accurate. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) were found at 0.0125µg/ml and 0.0495µg/ml, respectively. Conclusion: An RP-HPLC method which was relatively simple, accurate, rapid and precise was developed and its validation was performed for the quantitative analysis of empagliflozin in bulk and tablet dosage form (10 and 25 mg) in accordance to International Conference of Harmonization (ICH) Q2 (R1) guidelines. The proposed method may aid in routinely analyzing empagliflozin in pharmaceuticals.

Download Full-text