A Simple Stability Indicating Rp-Hplc-Dad Method For Concurrent Analysis Of Tenofovir Disoproxil Fumarate, Doravirine And Lamivudine In Pure Blend And Their Combined Film Coated Tablets

2021 ◽  
Author(s):  
Ramreddy Godela ◽  
Sowjanya Gummadi
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Concurrent Analysis

scholarly journals A validated stability indicating LC-MS compatible RP-HPLC assay and dissolution methods for marketed formulation Stribild

2018 ◽  
Vol 8 (6) ◽  
pp. 159-170
Author(s):  
U Harini ◽  
AKM Pawar
Keyword(s):  
Liquid Chromatography ◽  
Tenofovir Disoproxil Fumarate ◽  
In Vitro Dissolution ◽  
Array Detector ◽  
Forced Degradation ◽  
Dissolution Profile ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Validation Parameters ◽  
Pharmaceutical Industries

Objective: The prime objective of the current work is to develop a simple, rapid, efficient, economical and stability indicating LC-MS (liquid chromatography–mass spectroscopy) compatible RP - HPLC (reverse phase – high performance liquid chromatography) method for the analysis of emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), cobicistat (COB) and elvitegravir (ELV) in bulk, marketed formulation (Stribild) and in In-vitro dissolution method. Method: The chromatography was achieved on Unisol C18 column (250 × 4.0 mm, 3 µ) with a mobile phase combination of acetate buffer (adjusted with dilute glacial acetic acid to pH 4) and acetonitrile in gradient mode at a flow rate of 1mL/min and the detection was performed at 260 nm using PDA (photo diode array) detector. Forced degradation studies were performed and the % degradation under various stress conditions was calculated. The developed RP-HPLC method was applied for Stribild tablets to study the dissolution profile. Results: The retention times for emtricitabine, tenofovir disoproxil fumarate, cobicistat and elvitegravir were 5.7, 12.1, 16.3 and 19.4 min respectively. The % degradation was below 20% which is within the limits. The percent drug release was found to meet USP specification, i.e. not less than 80% of amount of labeled drug EMT, TDF, COB and ELV dissolved in 30min. Conclusion: The method was validated as per ICH guidelines and all the validation parameters were within the compendial requirements. The proposed method can be successfully adopted for the analysis of Stribild tablets in pharmaceutical industries. Keywords: Stribild, emtricitabine, tenofovir disoproxil fumarate, cobicistat, elvitegravir

scholarly journals RP-HPLC (STABILITY-INDICATING) BASED ASSAY METHOD FOR THE SIMULTANEOUS ESTIMATION OF DORAVIRINE, TENOFOVIR DISOPROXIL FUMARATE AND LAMIVUDINE

2021 ◽  
pp. 153-159
Author(s):  
V. L. N. BALAJI GUPTA TIRUVEEDHI ◽  
VENKATESWARA RAO BATTULA ◽  
KISHORE BABU BONIGE
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Uv Light ◽  
Volume Ratio ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Intermediate Precision ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
The Stability

Objective: In this study, a RP-HPLC (stability-indicating) based assay method for the estimation of doravirine (DRV), tenofovir disoproxil fumarate (TFF) and lamivudine (LMV) simultaneously in the tablets was described. Methods: The simultaneous analysis of DRV, TFF and LMV was done with HPLC system (Agilent 1100 series) and Luna Phenomenex C18 (250 mm × 4.6 mm × 5 μ) column with isocratic mobile phase (35% volume ratio of methanol and 65% volume ratio of 20 mmol ammonium formate, pH 5). Validation of assay method was done on sensitivity, linearity, accuracy, selectivity, precision, robustness and specificity. Results: The calibration curves were linear through the range of 25-200 µg/ml for DRV and 75-600 µg/ml for TFF and LMV. The percent relative standard deviation for intraday variation/precision, interday variation/precision, intermediate precision/ruggedness and robustness were lower than 2%. The recovery of LMV (99.09-99.76%), TFF (99.10-99.41%) and DRV (98.65-99.28%) confirmed the good accuracy. The stability of LMV, TFF and DRV in 0.1N NaOH, 3% peroxide, 0.1 N HCl, UV light and dry heat of 60 °C was determined. Conclusion: The results have allowed the method to be implemented in the tablets to quantify DRV, TFF, and LMV.

scholarly journals A new stability-indicating RP-HPLC method for the determination of dicyclomine hydrochloride and dimethicone combination in tablet dosage forms

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
J. Saroja ◽  
Anantha Lakshmi P.V. ◽  
Y. Rammohan ◽  
D. Divya Reddy
Keyword(s):  
Liquid Chromatography ◽  
Dosage Forms ◽  
Flow Speed ◽  
Hplc Method ◽  
Stability Indicating ◽  
Simultaneous Quantification ◽  
Rp Hplc ◽  
Tablet Formulations ◽  
Tablet Dosage

Abstract Background We describe a “stability-indicating liquid chromatography” technique for the estimation of dimethicone (DEC) and dicyclomine hydrochloride (DEH) in the established tablet formulations. Individual quantification of DEH and DEC was reported. But simultaneous quantification of DEH and DEC was lacking. DEH and DEC were analysed on an “XTerra C18 column (250 mm × 4.6 mm, 5 μm)” with the mobile phase solvent run isocratically with 0.1M K2HPO4-acetonitrile (55:45, v/v) on a flow speed of 1.0 mL/min. Results The chromatographic run period for the DEC and DEH assay was 6.0 min with retention times of 2.134 and 2.865 min, respectively. The method was validated for accuracy (99.453 to 100.417% and 99.703 to 100.303% recovery values for DEH and DEC, respectively), precision (RSV value 0.135% for DEC and 0.171% for DEH), linearity (5–15 μg/mL for DEH and 20–60 μg/mL for DEC), selectivity (no hinderance from excipients) and specificity (no hinderance from degradants) recovery. Conclusion The developed stability-indicating liquid chromatography process was well applied to established tablet formulations.

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