Sensitive and validated TLC densitometry method coupled with fluorescence detection for quantitative determination of the newly co-formulated drugs, celecoxib and amlodipine besylate in tablet dosage form

Abstract

New, sensitive, rapid, cost-effective, and validated stability-indicating thin layer chromatographic (TLC) method coupled with fluorescence (FL) detection was developed for the quantitative analysis of celecoxib (CEL) and amlodipine besylate (AMLO) in their laboratory prepared binary mixture using the non-fluorescent TLC silica gel 60 plates. Ethyl acetate: diethylamine: 1-propanol (9:1:0.2, V/V) was used as a developing system. The retention factor (Rf) for each drug was 0.80 ± 0.03 and 0.44 ± 0.01 for CEL and AMLO, respectively. The plates were excited at 264 nm for the simultaneous FL measurement of CEL and AMLO, the calibration curves were linear over a concentration ranges of 30.0–300.0 ng/band and 15.0–150.0 ng/band with mean percentage recoveries of 99.80 ± 0.85 and 99.80 ± 0.77 For CEL and AMLO, respectively. The developed method was applied for the stability studies of the cited drugs in their laboratory prepared binary mixture and the forced degradation products were determined when present in presence of the pure drugs so the method can be considered as a stability-indicating one and it was validated as per ICH guidelines and proved to be accurate and precise.

Comparative HPTLC study for simultaneous determination of ivabradine and metoprolol using UV and fluorescence detectors

“…For UV detection at 275 nm, TLC pre-coated silica gel aluminum plates 60 F 254 were used for simultaneous determination of IVA and MET in bulk and pharmaceutical dosage form. For fluorescence reflection mode detector at lambda excitation wavelength λex of 260 nm and K320 as cut off, the TLC silica gel plates 60 F 254 were exposed to hydrochloric acid vapors for few minutes in a closed chamber which break down the fluorescent material on TLC [ 20 ]. Consequently, the plates were converted into non-fluorescent plate (TLC silica gel 60) after air drying for an hour.…”

A Review on Simultaneous Determination of Anti-Hypertensive Drug Combinations Containing Amlodipine Besylate using Chromatographic Analysis

“…The retention value for drugs were at recorded at 0.80 ± 0.03 and 0.44 ± 0.01 for Celecoxib and Amlodipine besylate respectively [31] . The method could estimate the binary mixture samples and forced degradation samples with required sensitivity [48] .…”

First derivative synchronous spectrofluorimetric method for the simultaneous determination of tramadol and celecoxib in their dosage forms and human plasma

“…1), classified as a COX-2 selective NSAID, is commonly prescribed for patients with osteoarthritis and rheumatoid arthritis, being more advantageous than other NSAIDs because of its reduced gastrointestinal side effects [8]. Several analytical methods are reported in the literature for celecoxib solely or in combinations such as HPLC [9][10][11][12], spectrophotometric methods [13][14][15], TLC [16][17][18] in addition to electrochemical methods [19][20][21]. 1), an analgesic medication with dual monoaminergic reuptake inhibitory and opioid receptor agonist activities, is used for neuropathic pain, osteoarthritic pain as well as low back and rheumatoid arthritis [22].…”

“…Celecoxib (4‐[5‐(4‐methylphenyl)‐3‐(trifluoromethyl)‐1H‐pyrazol‐1‐yl] benzene sulfonamide) (Figure 1), classified as a COX‐2 selective NSAID, is commonly prescribed for patients with osteoarthritis and rheumatoid arthritis, being more advantageous than other NSAIDs because of its reduced gastrointestinal side effects [8]. Several analytical methods are reported in the literature for celecoxib solely or in combinations such as HPLC [9–12], spectrophotometric methods [13–15], TLC [16–18] in addition to electrochemical methods [19–21].…”