Effect of Ascorbic Acid on dissolution stability of Rifampicin in market fixed dose combination products for Tuberculosis

Subashini Rajaram; Abirami Murugan; Nidhina C.M

Subashini Rajaram Swamy Vivekanandha College of Pharmacy
Abirami Murugan Swamy Vivekanandha College of Pharmacy
Nidhina C.M Life Pharmacy,

Keywords: Rifampicin, ASC, 3-Formyl rifamycin SV, FDC, HPLC

Abstract

Degradation of rifampicin (RIF) to insoluble and poorly absorbed 3-Formyl rifamycin SV (3-FRSV) in acidic environment is a major concern which leads to reduction in the bioavailability of RIF and is further influenced by the presence of isoniazid (INH) in the stomach after ingestion. It is recommended that addition of ascorbic acid (ASC) in dissolution medium, in plasma as antioxidant to stabilize RIF from degradation and also daily intake of ASC to control tuberculosis (TB).Though the effect of ASC on fixed dose combination (FDC) products has not been traversed and hence examined in the present study. The rate of degradation of RIF to 3-FRSV in the presence of ASC in dissolution medium (0.1 N HCl) on market formulations was estimated by Dual Wavelength UV–Vis. spectrophotometry (DW spectrophotometry) and High performance liquid chromatography (HPLC) method. Addition of ASC in FDC formulations lowered significantly formation of 3-FRSV or degradation of RIF as compared to that without ASC in in-vitro. Our study proposed that co-package of ASC with fixed dose combination products (FDC) can protect RIF degradation in the acidic environment and in-vivo investigation needed to predict the bioavailability of RIF in FDC products in the presence and absence of ASC for effective control of TB.

Author Biographies

Subashini Rajaram, Swamy Vivekanandha College of Pharmacy

Swamy Vivekanandha College of Pharmacy,
Namakkal, Tamilnadu, India.

Abirami Murugan, Swamy Vivekanandha College of Pharmacy

Swamy Vivekanandha College of Pharmacy,
Namakkal, Tamilnadu, India.

Nidhina C.M, Life Pharmacy,

Life Pharmacy,
Al Barsha,
Dubai-UAE.

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