Development and Validation of Venlafaxine Hydrochloride in Bulk and in Capsule Formulation by HPTLC

A simple, sensitive and rapid high performance thin layer chromatographic (HPTLC) method has been developed and validated for quantitative estimation of Venlafaxine hydrochloride in bulk and in capsule formulation. The drug was chromatographed on silica gel 60F254TLC plate using methanol: ammonia (4.5:0.5v/v) as mobile phase. Densitometric scanning of was carried out at 224 nm and resolution was found with Rf value 0.65±0.02. The linear regression analysis for the calibration plots showed good linear relationship with ????2=0.998 in concentration range 500-3000ng/spot. The minimum detectable amount was found to be 7.7ng/spot, whereas the limit of quantitation was found to be 23.3ng/spot. The method was validated for precision, recovery, repeatability and robustness as per the ICH guidelines. Statistical analysis of the data showed that the method is precise, accurate, reliable, reproducible, and selective for the analysis of Venlafaxine hydrochloride. The proposed method also indicates no interference of excipients from capsule formulation.

[1]  Ju‐Seop Kang,et al.  Development of a LC-MS/MS for Quantification of Venlafaxine in Human Plasma and Application to Bioequivalence Study in healthy Korean Subjects , 2014 .

[2]  B. Kiran.  Validation of Venlafaxine in Pharmaceutical Dosage by Reverse Phase HPLC , 2014 .

[3]  B. Ramesh,et al.  Stability-Indicating HPTLC Method for Analysis of Venlafaxine Hydrochloride, and Use of the Method to Study Degradation Kinetics , 2011, JPC – Journal of Planar Chromatography – Modern TLC.

[4]  T. Mani,et al.  HPTLC Analysis of Venlafaxine Hydrochloride in the Bulk Drug and Tablets , 2010, JPC – Journal of Planar Chromatography – Modern TLC.

[5]  S. Schreiber,et al.  Venlafaxine and mirtazapine , 2002, Journal of Molecular Neuroscience.

[6]  E. Vlachou,et al.  Venlafaxine HCl in the treatment of painful peripheral diabetic neuropathy. , 2000, Diabetes care.

[7]  J. Davis,et al.  Painful peripheral diabetic neuropathy treated with venlafaxine HCl extended release capsules. , 1999, Diabetes care.

[8]  Z. Rogóż,et al.  Pharmacological effects of venlafaxine, a new antidepressant, given repeatedly, on the α1-adrenergic, dopamine and serotonin systems , 1999, Journal of Neural Transmission.

[9]  L. Ereshefsky.  Drug-Drug Interactions Involving Antidepressants: Focus on Venlafaxine , 1996, Journal of Clinical Psychopharmacology.

[10]  P. Benfield,et al.  Venlafaxine. A review of its pharmacology and therapeutic potential in depression. , 1995, Drugs.

[11]  V. Ellingrod,et al.  Venlafaxine: a heterocyclic antidepressant. , 1994, American journal of hospital pharmacy.

[12]  E. sanders-Bush,et al.  The serotonin/norepinephrine-link in brain. II. Role of serotonin in the regulation of beta adrenoceptors in the low agonist affinity conformation. , 1988, The Journal of pharmacology and experimental therapeutics.