Asian Journal of Pharmaceutical Analysis

Rucha K. Patel ¹, Nilam M. Patel ¹, Samir K. Shah ¹

Affiliations
1 Sardar Patel College of Pharmacy, Vidhyanagar-Vadtal Road, Bakrol, Anand, Gujarat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Ferrous Ascorbate and Folic Acid in their combined dosage form using simultaneous equation and first order derivative method. In Simultaneous Equation method, Ferrous Ascorbate and Folic Acid were quantified using their absorptivity values of at selected wavelengths, i.e., 265 nm and 344 nm respectively. In First order Derivative method, Ferrous Ascorbate showed zero crossing point at 265.78 nm while Folic Acid showed zero crossing point at 280.34 nm. The dA/dλ was measured at 280.34 nm for Ferrous Ascorbate and 265.78 nm for Folic Acid and calibration curves were plotted as dA/dλ versus concentration, respectively. The method was found to be linear in the range of 10-80 μg/ml for Ferrous Ascorbate and 1-8 μg/ml for Folic Acid. The accuracy of the proposed methods was evaluated by recovery studies and good recovery results were obtained. The method was successfully applied for simultaneous determination of Ferrous Ascorbate and Folic Acid in combined dosage form.

Keywords

Ferrous Ascorbate, Folic Acid, Vierodt’s Method, First Order Derivative Method.

Full Text

     

Jinal N. Tandel ¹, Radhika V. Bhatt ¹, Nilam M. Patel ¹, Samir K. Shah ²

Affiliations
1 Department of Quality Assurance, Sardar Patel College of Pharmacy, Vidyanagar-Vadtal Road, Bakrol,(388315) Gujarat, IN
2 Department of Pharmacology, Sardar Patel College of Pharmacy, Vidyanagar-Vadtal Road, Bakrol,(388315) Gujarat, IN

Abstract

Clomipramine Hydrochloride is Tricyclic antidepressants (TCAs) drug which cause increased concentration of monoamines in the synaptic cleft, ultimately resulting in antidepressant effect. Literature reveals that all the reported methods are developed for estimation of Clomipramine Hydrochloride (CLH) in bulk and solid dosage form. My research is based on estimation of CLH and its related substances from capsule dosage form by HPLC method. A rapid, precise, selective and sensitive and accurate stability-indicating High Performance Liquid Chromatographic (HPLC) method for estimation of Clomipramine Hydrochloride and its related substances from capsule dosage form was developed and validated in the present work. The chromatographic separation was performed by using BDS Hypersil C₁₈, 250 X 4.6 mm, 5 μ with 2 gm /L Tetra Butyl Ammonium Hydrogen Sulphate (TBAS) in Water (pH 2.5) : Methanol (40:60 v/v) mobile phase, at a flow rate of 1.2 ml/min. The method was validated according to ICH guidelines. The effluent was monitored using a UV detector set at 252nm. The retention time for CLH was observed at 6.2 min. Impurity spiked A, B, C, are retained at 7.8, and 9.4, 3.6, min respectively. The linearity of CLH and impurities was in the range of 1050 - 1800 μg/ml and 0.7 - 4.5μg/ml respectively. The developed method was successfully applied to the analysis of the drugs in their commercial dosage form.

Keywords

Clomipramine Hydrochloride (CLH), Impurity, HPLC, Stability, Validation.

Full Text