International Journal of Drug Delivery Technology
Volume 14, Issue 3

Preformulation Studies of Pitavastatin Calcium– A Primary Step in Further Design of Chronotherapeutic Formulation Synchronized with Circadian Rhythm

V Anusha1, MS Umashankar1*, Y Ganesh kumar2

1Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Tamil Nadu, India.

2Department of Pharmaceutics, KVK College of Pharmacy, Hyderabad, Telangana, India. 

Received: 20th February, 2024; Revised: 27th March, 2024; Accepted: 15th August, 2024; Available Online: 25th September, 2024 

ABSTRACT

The principal goal and objective of this present research work were to perform a preformulation analysis of Pitavastatin calcium to produce a further stable, efficient chroomodulated drug delivery system. Pitavastatin calcium was analyzed to study its micrometric properties, equilibrium solubility profile in different media, and determination of purity by subjecting to fourier- transform infrared spectroscopy (FTIR) studies, by determining the absorption maxima in the medium along with differential scanning Calorimetry- DSC. Spectral analysis of UV studies and calibration curve plotting was done for further analytical research. The melting point was analyzed, and PXRD studies were conducted to identify the crystallinity. The Pitavastatin calcium micromeritic properties were found to be good with bulk density- 0.408 g/mL, tapped density 0.476 g/mL, Carr’s index 14.2%, Hausner’s ratio 1.16 with 32.0050 angle of repose. The equilibrium solubility study indicates drug has peak solubility in media 0.1 N Hcl and reduced solubility in distilled water. The infrared spectrum indicated peaks corresponding to functional groups conforming to the purity. The UV spectrum exhibited absorption maxima at 250 nm in media 0.1N HCl and 245 in pH phosphate buffer 6.8 and in all other mediums, which is the same as the standard literature indication. The calibration curve exhibited linearity in accordance with Beer Lambert’s law. The PXRD studies produced 2θ values corresponding to pitavastatin calcium as per literature conforming to the crystallinity. The Preformulation analysis concludes that the drug was pure pitavastatin calcium with corresponding absorption maxima, an infrared spectral functional group with crystallinity. It specifies that the drug mandates the improvement of solubility for further formulation development.

Keywords: Pitavastatin calcium, Solubility, Infrared spectrum, Purity, Crystallinity. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.3.46

How to cite this article: Anusha V, Umashankar MS, Kumar YG. Preformulation Studies of Pitavastatin Calcium– A Primary Step in Further Design of Chronotherapeutic Formulation Synchronized with Circadian Rhythm. International Journal of Drug Delivery Technology. 2024;14(3):1578-1585.

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