Abstract
Objective: The preliminary goal was to develop and validate 1st order derivative spectroscopic method for quantitative analysis of Pamabrom (PAMA) which is a xanthine diuretic and ibuprofen (IBU) which is a non-steroidal anti-inflammatory agent from its synthetic mixture.
 Methods: Analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methanol as solvent. Quantification of PAMA was carried out at zero cross over point of IBU that is 291 nm and for IBU, it was achieved at 278 nm which is zero cross over point of PAMA. Method was validated according to ICH Q2 R1 guidelines.
 Results: Method showed a linear response in the range of 2-12 µg/ml of PAMA and 20-120 µg/ml of IBU. Method was found to be accurate with recovery between 99.7–100.9 % for PAMA and 100.3–100.7 % for IBU. The method was found to be accurate and precise for quantitative analysis of PAMA and IBU.
 Conclusion: The developed method was successfully validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of a synthetic mixture of PAMA and IBU.
Highlights
Pamabrom (PAMA) belongs to the class of xanthene diuretics, which basically contains purine moiety and is approved by US FDA for treatment of menstruation bloating, premenstrual dysphoric disorders, while ibuprofen (IBU) is non-steroidal anti-inflammatory (NSAID’s) drug that is propionic acid derivative which is approved by Indian pharmacopoeia (IP), United states pharmacopoeia (USP) and Japanese pharmacopoeia (JP) for management of mild-to-moderate pain associated with dysmenorrhea and arthritis [1-7]. 40–90 % of women of childbearing age complained of primary dysmenorrhea, which is characterized in cyclic pelvic pain during the menstrual period, vomit and headache
Among the all NSAID’s, IBU has shown better tolerability which forms the basis of combining PAMA and IBU for treatment of pain associated with renal calculi and dysmenorrhea
Three different ZCP at 278 nm, 316 nm and 245 nm was observed in overlain D1 spectra of PAMA
Summary
Pamabrom (PAMA) belongs to the class of xanthene diuretics, which basically contains purine moiety and is approved by US FDA for treatment of menstruation bloating, premenstrual dysphoric disorders, while ibuprofen (IBU) is non-steroidal anti-inflammatory (NSAID’s) drug that is propionic acid derivative which is approved by Indian pharmacopoeia (IP), United states pharmacopoeia (USP) and Japanese pharmacopoeia (JP) for management of mild-to-moderate pain associated with dysmenorrhea and arthritis [1-7]. 40–90 % of women of childbearing age complained of primary dysmenorrhea, which is characterized in cyclic pelvic pain during the menstrual period, vomit and headache. Pamabrom (PAMA) belongs to the class of xanthene diuretics, which basically contains purine moiety and is approved by US FDA for treatment of menstruation bloating, premenstrual dysphoric disorders, while ibuprofen (IBU) is non-steroidal anti-inflammatory (NSAID’s) drug that is propionic acid derivative which is approved by Indian pharmacopoeia (IP), United states pharmacopoeia (USP) and Japanese pharmacopoeia (JP) for management of mild-to-moderate pain associated with dysmenorrhea and arthritis [1-7]. Among the all NSAID’s, IBU has shown better tolerability which forms the basis of combining PAMA and IBU for treatment of pain associated with renal calculi and dysmenorrhea. PAMA and IBU are officially quantified by HPLC [8]. Several analytical methods are available which can determine IBU and PAMA individually or in combination with another drug [9-26]. Literature review revealed one complex RP-HPLC method for quantitative analysis of PAMA and IBU
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