“…FLU and PRO are used in combination for migraine prophylaxis[34]. Literature survey reveals that various analytical methods like UV[56], HPLC[789101112], HPTLC[13], and GC[14] are reported for the individual drugs and in combination with others and one paper on UV using methanol as solvent for simultaneous estimation of FLU and PRO[15]. However, no method is reported for simultaneous estimation of these two drugs by HPTLC.…”
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.
“…FLU and PRO are used in combination for migraine prophylaxis[34]. Literature survey reveals that various analytical methods like UV[56], HPLC[789101112], HPTLC[13], and GC[14] are reported for the individual drugs and in combination with others and one paper on UV using methanol as solvent for simultaneous estimation of FLU and PRO[15]. However, no method is reported for simultaneous estimation of these two drugs by HPTLC.…”
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.
“…Flunarizine dihydrochloride is official in BP 6 . Literature survey reveals that some methods have been developed for their determination by HPLC [7][8][9] or spectrophotometry [10][11][12] either alone or in combination, but no method was found for the selected combined dosage form by first order derivative UV spectrophotometry. Derivative spectrophotometry [13][14][15] is one of the advanced spectrophotometric techniques useful for determination of quantitative and qualitative analysis.…”
The first order derivative of UV spectrometry method for simultaneous determination of Propranolol hydrochloride (PRO) and Flunarizine dihydrochloride (FLU) in pure bulk drug and combined dosage form was found to be simple, accurate, fast, precise and reproducible. The first derivative values measured at 289nm for PRO and 253nm for FLU. The linearity for zero order derivative method was carried out by using the concentration range 4-28µg/ml for PRO and 3-7µg/ml for FLU. The coefficient correlation of PRO and FLU for zero order was found to be 0.9995 and 0.9991 respectively. At zero crossing point of PRO (289nm) FLU showed a measurable derivative absorbance where as at the zero crossing point of FLU (253nm), PRO showed appreciable derivative absorbance value. The coefficient correlation of PRO and FLU for first order derivative was found to be 0.9991 and 0.9995 respectively. Precision study showed that % RSD was within the range of acceptable limits (<2). The % recovery for PRO and FLU was found to be in the range of 98-102% and 100-101% respectively. The percentage assay was found to be as 99.5 and 100.12% for PRO and FLU. The results of analysis have been validated as per ICH Q2 (R1) guidelines. This method has applied successfully for the determination of PRO and FLU in its combination with a high percentage of recovery good accuracy and precision. . Development and validation of first order derivative UV Spectrophotometric method for simultaneous estimation of Propranolol hydrochloride and Flunarizine dihydrochloride in bulk and combined dosage form. Int. Res. J.
“…The current approved pharmacopoeia HPLC method for the determination of the main related substances is described in the European Pharmacopoeia [2] . Other methods for the HPLC analysis of flunarizine dihydrochloride in tablets have been detailed in the literature [3] . Fig.…”
A rapid selective method for the analysis of flunarizine and its associated impurities was developed and validated according to ICH guidelines. The separation was carried out using a Thermo Scientific Hypersil Gold C18 column (50 mm×4.6 mm i.d., 1.9 μm particle size) with a gradient mobile phase of acetonitrile–ammonium acetate–tetrabutylammoniumhydrogen sulfate buffer, at a flow rate of 1.8 mL/min and UV detection at 230 nm. Naturally aged samples were also tested to determine sample stability. A profile of sample and impurity breakdown was also presented.
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