Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms

Azeem, Adnan; Rizwan, Mohammad; Ahmad, Feroz; Iqbal, Zeenat; Khar, Roop K.; Aqil, Mohd.; Talegaonkar, Sushama

doi:10.1556/achrom.21.2009.2.8

Cited by 4 publications

(3 citation statements)

References 26 publications

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“…The applicability of the proposed method for the determination of buspirone hydrochloride in Freeton 5 and Buscalm 5 tablets has been tested. The results of the proposed method were statistically compared with those of the reference HPLC method [5] using point and interval hypothesis tests. Table IV showed that the calculated t-(paired) and F-values at 95 % confidence level are less than the tabulated t-value (2.036 at υ = 8) and F-value (6.39 at υ = 4,4), thus confirming no significant difference between the performance of the proposed method and the reference method.…”

Section: Validationmentioning

confidence: 99%

“…The assay of buspirone hydrochloride in bulk and formulations is cited in The British Pharmacopoeia [1] which is based on liquid chromatography. In view of the great importance of the drug in terms of its optimum oral dose and wide use, various analytical methods have been reported which include high performance liquid chromatography [2][3][4][5][6], voltammetry [7,8], radioimmunoassay [9], capillary GC [10], flow injection analysis with tubular membrane ion-selective electrode [11], spectrofluorimetry [12], and spectrophotometry [13,14]. The extractive spectrophotometric method [15] has also been utilized for determination of buspirone hydrochloride based on the formation of coloured ion pair complex of the drug with bromocresol green.…”

Section: Introductionmentioning

confidence: 99%

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Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method

Azmi¹

2015

SJAC

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An extractive spectrophotometric method has been developed for the determination of buspirone HCl in tablets. It was based on the ion-pair complex formation between buspirone and bromothymol blue in presence of disodium hydrogen phosphate and citric acid buffer solution of pH 4.0 which is extractable in chloroform. The extracted complex showed maximum absorbance at 412 nm. Beer's law was obeyed in the concentration range of 1.25-30 µg ml-1. Various factors affecting the reaction conditions were carefully studied and optimized. Validation parameters based on the guidelines of International Conference on Harmonisation, USA were followed. Effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of buspirone HCl. Limits of detection and quantitation were 0.165 and 0.499 µg ml-1 , respectively. Proposed method has been successfully applied for the determination of buspirone HCl in pharmaceutical formulations. High performance liquid chromatographic method was employed using 250 mm × 4.6 mm i.d., 5-µm particle, reversed phase C18 column with 70:30 (v/v) methanol-0.01M NaH 2 PO 4 buffer as a mobile phase at a flow rate of 0.8 ml min-1 and UV detection at 240 nm for best separation of buspirone. Results obtained by the proposed method were statistically compared with the HPLC reference method using t-and F-values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of buspirone HCl in pharmaceutical formulations.

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Section: Validationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method

Azmi¹

2015

SJAC

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“…1a), 8-[4-(4-pyrimidin-2-yl-piperazin-1-yl) butyl]-8-azaspiro decane-7,9-dione hydrochloride, 1,2 is an anxiolytic drug that has dopaminergic, noradrenergic and serotonin modulating properties and is used in the treatment of generalized anxiety disorders. 3 Buspirone belongs to the largest and most thoroughly investigated arylpiperazine class of serotonin 5-HT 1A receptor ligands. 4 Buspirone has an advantage over other benzodiazepines in that it causes less sedation and impairment of psychomotor performance.…”

Section: Introductionmentioning

confidence: 99%

A sensitive LC-ESI-MS/MS method for the quantification of low concentrations of buspirone in human plasma

Joshi¹,

Rao²,

Singh³

et al. 2013

Anal. Methods

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A validated stability-indicating LC method for estimation of etoposide in bulk and optimized self-nano emulsifying formulation: Kinetics and stability effects

Akhtar

Talegaonkar

Khar

et al. 2013

Saudi Pharmaceutical Journal

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The present investigation was aimed to establish a validated stability-indicating liquid chromatographic method for the estimation of etoposide (ETP) in bulk drug and self-nano emulsifying formulation. ETP was successfully separated from the degradation products formed under stress conditions on LiChrospher 100 C18 reverse-phase column (a 250 mm × 4.6 mm i.d., 5-μm particle size) using 55:45 (v/v) acetonitrile-phosphate buffer saline (pH 4.5) as the mobile phase, at a flow rate of 1.0 mL min(-1) and detection at 283 nm. The response was a linear function of analyte concentration (R(2) > 0.9997) over the concentration range of 0.05-50 μg mL(-1). The method was validated for precision, accuracy, robustness, sensitivity and specificity. The % recovery of ETP at three different levels (50%, 100% and 150%) ranged between 93.84% and 100.06% in optimized self-nano emulsifying formulation, Etosid® soft-gelatin capsule and Fytosid® injection. First-order degradation kinetics of ETP were observed under acidic and alkaline conditions. The method was also applied for the stability assessment of self-nano emulsifying formulation under accelerated conditions, the formulation was found to be stable at all storage conditions with the shelf-life of 2.37 years at 25 °C. The method holds promise for routine quality control of ETP in bulk, pharmaceutical formulations as well as in stability-indicating studies.

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Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms

Cited by 4 publications

References 26 publications

Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method

Determination of Buspirone HCl in Commercial Dosage Forms by Extractive Spectrophotometric Method and Comparison by HPLC Method

A sensitive LC-ESI-MS/MS method for the quantification of low concentrations of buspirone in human plasma

A validated stability-indicating LC method for estimation of etoposide in bulk and optimized self-nano emulsifying formulation: Kinetics and stability effects

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