Abstract

DEVELOPMENT AND VALIDATION OF TWO UV SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF ILAPRAZOLE, AND LEVOSULPIRIDE IN TABLET DOSAGE FORM

Mansi Patel*, Purvi A. Shah, Kalpana Patel and Tejal Gandhi

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Abstract

Two simple, rapid and precise UV spectroscopic methods namely First order Derivative (Method I), and Ratio first order derivative (Method II) have been developed for the simultaneous determination of Ilaprazole (ILA) and Levosulpiride (LEVO). The first order derivative absorption at 305.51 nm (zero cross point of Ilaprazole) was used for quantification of Levosulpiride and 321.88 nm (zero cross point of Levosulpiride) for quantification of Ilaprazole, linear concentration range for ILA and LEVO was 2-12 μg/ml and 15-90 μg/ml with regression coefficient 0.9994 and 0.9990 respectively. The second method is based on ratio first order derivative spectrophotometry, at 310.70 nm and at 277.73 nm, with regression coefficient 0.9992 and 0.9997 respectively. The proposed methods were validated according to ICH guidelines for evaluation of accuracy, precision, sensitivity etc. The obtained relative standard deviation i.e. less than 2% demonstrated that proposed methods were accurate and precise and can be employed for routine analysis in quality control laboratories eliminating the need of prior separation of the pharmaceutical mixtures.

Keywords: Ilaprazole, Levosulpiride, First order derivative method, Ratio first order derivative method, validation.