Development and validation of a HPTLC method for simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in capsule dosage form

Abstract

A simple, precise, accurate, and rapid high-performance thin layer chromatographic method has been developed and validated for the simultaneous quantitation of flunarizine dihydrochloride and propranolol hydrochloride in a combined capsule dosage form. The method was carried out on precoated silica gel 60 F254 TLC aluminum plate, (20×10 cm2). The solvent system was ethyl acetate:methanol:glacial acetic acid in the proportion of 8:1:1, (v/v/v). Rf value for flunarizine dihydrochloride and propranolol hydrochloride was found to be 0.62±0.02 and 0.18±0.02, respectively. The linearity regression analysis for calibration showed 0.999 and 0.999 for flunarizine dihydrochloride and propranolol hydrochloride with respect to peak area and height in the concentration range of 50-350 ng/spot and 500-3500 ng/spot, respectively. Accuracy of recovery studies was found to be 98-100.28 and 99.11-99.45% for flunarizine dihydrochloride and propranolol hydrochloride, respectively. The amounts of drug in marketed formulation were 100.5 and 101.25% of flunarizine dihydrochloride and propranolol hydrochloride, respectively. The method developed can be used for routine analysis in bulk drug and capsule dosage form.

Ft-Ir Spectroscopic Approach for the Quantitative Analysis of Few Commercial Drugs in Bulk and Pharmaceutical Formulations

“…The results in table 5 reveal that the methods are successful for the determination of drugs and that the excipients in the dosage forms do not interfere. The results were compared to the available validated reported [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] methods on each drug and the results agree well with the claim and also are in agreement with the results obtained by the literature method. Statistical evaluation results were used to test the accuracy by Student's t-test and precision by F-test (Table 6) which revealed no significant change was observed between the literature method and proposed method at the 95 % confidence level with reference to accuracy and precision.…”

“…FNZ has less affection to VGCS (Voltage dependent Calcium channels) and works by antagonizing the calcium modulating protein in the cells but not inhibiting the calcium entry into the cells. Extensive literature analysis confirmed that FNZ is determined by various methods such as Spectrophotometry [14], RP-HPLC [15], HPTLC [16], Spectrofluorimetry [17] and Titrimetry [18].…”