EFFECT OF LUBRICANTS ON THE STABILITY OF CLOPIDOGREL BISULPHATE TABLETS Muhammad Amer1 , Zubair Saeed2 , Saeed Ur Rashid Nazir2 , M. Nadeem3 , Misbah Sultana4

The objective of the current study was to develop oral formulation of Clopidogrel Bisulphate 75mg tablet and perform the accelerated stability study to obtain the stable product by using the various lubricants like magnesium stearate, stearic acid and pregelatinized starch. Three different formulations of tablets were prepared and coded as F1, F2 and F3 containing the various lubricants i.e. magnesium stearate, stearic acid and combination of magnesium stearate and pregelatinized starch respectively. Tablets were prepared by direct compression method and the compressed tablets were film coated. The tablets were placed in a stability chamber and accelerated stability studies at 400C and 75% RH were carried out at time 0, 3 and 6 months duration. In accelerated stability study, various tests were performed including hardness, disintegration, chemical assay and in-vitro dissolution test. After preparation of tablets, the physical and chemical parameters of tablets at zero period of time were tested, and were found within their specification. After test the tablets were kept in the stability chamber for six months. After three and six months the physical and chemical parameters of tablets were also tested. According to the results, the formulations containing the magnesium stearate and stearic acid degraded with the passage of time but the formulation containing the combination of pre-gelatinized starch and magnesium stearate were more stable as compared to the formulations containing the lubricants as magnesium stearate and stearic acid. Key words: Clopidogrel Bisulphate, Pregelatinized starch, Accelerated stability studies, In-vitro dissolution