Development and validation of TLC–densitometric method for simultaneous determination of two binary antihypertensive mixtures containing felodipine in fixed dose combinations

Abstract

A new densitometric thin-layer chromatographic method has been developed for simultaneous determination of two binary mixtures containing felodipine in combination with either metoprolol (mixture I) or ramipril (mixture II). The two mixtures were quantitatively separated on 60 F254 silica gel plates using toluene-ethyl acetate-methanol-ammonia as mobile phase with UV detection at 233 and 229 nm for mixtures I and II, respectively. The studied drugs were satisfactorily resolved with retention factor (Rf ) values of 0.34 ± 0.03 and 0.65 ± 0.03 for metoprolol and felodipine, respectively, in mixture I and 0.35 ± 0.03 and 0.74 ± 0.03 for ramipril and felodipine, respectively, in mixture II. Linearity ranges were 2000-7000 and 200-700 ng/band for metoprolol and felodipine, respectively, in mixture I and 1500-4000 ng/band for both ramipril and felodipine in mixture II. Correlation coefficient (r) values were 0.9968 for both metoprolol and felodipine in mixture I and 0.9993 for ramipril and 0.9989 for felodipine in mixture II. The method has been validated according to International Conference on Harmonization guidelines and has been successfully applied for determination of the studied drugs in their dosage forms without interference from commonly encountered excipients.

RP-HPLC method development and validation for simultaneous estimation of ramipril and felodipine

“…The results showed in Table 4 declares that slight modifications did not affect the resolution and tailing factor, indicating good robustness of the HPLC method. Table 5 showed statistical comparisons of the results obtained by the proposed method and reported method [32]. The calculated t-and F-values were less than the theoretical ones indicating that there was no significant difference between the proposed and the reported methods with respect to accuracy and precision.…”

“…On the other hand, FLD was determined individually by UV spectroscopy [17][18][19][20], HPLC [18,[21][22][23], spectrofluorimetric [24], gas chromatography [25] and electrochemical methods [26,27]. Meanwhile, some spectrophotometric [28,29], HPLC [28][29][30][31] and HPTLC [32] methods were reported for the simultaneous determination of both drugs.…”

“…Robustness study for the proposed HPLC method. Statistical analysis of results obtained by the proposed and reported method[32] for the determination of ramipril/felodipine in their pharmaceutical formulation.…”

Development and Validation of Stability Indicating Assay Method for Determination of Felodipine in Tablet Dosage Form

“…A literature survey revealed that several HPLC [7][8][9][10][11][12][13][14][15] , SFC. [16] References [17][18] are helpful in performing validation properly and HPTLC in combination reported [19][20] but no HPTLC method reported for stability study of FEP. Therefore, it was thought of interest to develop simple, rapid, accurate, specific and precise HPTLC method for the analysis of felodipine (FEP) in its tablet formulation.…”

Two selective HPTLC methods for determination of some angiotensin II receptor antagonists in tablets and biological fluids

“…HPTLC is now becoming a routine analytical technique. It has many advantages over other analytical techniques, which include the small amount of mobile phase required, the speed of the method, stationary phase discharge and the posibility of analysis of many samples and its standard at the same time (El‐Kommos et al, ; Mohamed et al, , ; Bartsch et al, ). It thus reduces analysis time and cost per analysis; moreover, HPTLC does not suffer from pH restrictions and measurement can be carried out in pH 0.5 or lower.…”